JUNE 2015
VOL. 105 NO. 6
A good complaints system – solution to SA’s medicolegal mayhem? 425 Non-alcohol-related Wernicke’s encephalopathy 442 Repair of laparoscopic bile duct injuries 451, 454 Management of burns begins at home … with prehospital cooling 452, 457 Paediatric dental chair sedation 453, 461 The South African Surgical Outcomes Study 465 Acute preoperative beta-blockade harms hypertensive vascular surgery patients 476 Predictors at diagnosis for poor-outcome severe Crohn’s disease 480
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June 2015
VOL. 105 NO. 6
GUEST EDITORIAL
SAMJ
425
A good complaints system G Howarth, J Tiernan, G Gillespie, P Carstens
EDITOR-IN-CHIEF Janet Seggie, BSc (Hons), MD (Birm), FRCP (Lond), FCP (SA)
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EDITOR’S CHOICE
DEPUTY EDITOR Bridget Farham, BSc (Hons), PhD, MB ChB
CORRESPONDENCE 429
EDITORS EMERITUS Daniel J Ncayiyana, MD (Groningen), FACOG, MD (Hon), FCM (Hon) JP de V van Niekerk, MD, FRCR
Patient satisfaction with emergency departments Z Mahomed, L Wallis, F Motara
IZINDABA 430 431 432 434 435
Stellenbosch University: Africa’s first WHO Bioethics Collaborating Centre Healthcare workers baulk at caring for contagious patients Judge nudges dormant euthanasia draft law The Fabricius decision on the Stransham-Ford case – an enlightened step in the right direction Robotic computer system develops high-skill ‘technosurgeons’
SAMJ FORUM
437
RECOMMENDATIONS Management of pulmonary hypertension M R Essop, N Galie, D B Badesch, U Lalloo, A G Mahomed, D P Naidoo, M Ntsekhe, P G Williams
440
HEALTHCARE DELIVERY Rural district hospitals – essential cogs in the district health system – and primary healthcare re-engineering K W D P le Roux, I Couper
CLINICAL ALERT 442 Encephalopathy after persistent vomiting: Three cases of non-alcohol-related Wernicke’s encephalopathy K Antel, N Singh, B Chisholm, J M Heckmann 444
CLINICAL PRACTICE A bedside system for clinical grading of parotid gland enlargement* M Tshifularo
446
PERSONAL VIEW Reflections of a retiree: 40 years in public service at Chris Hani Baragwanath Academic Hospital* K R L Huddle
HMPG CEO AND PUBLISHER Hannah Kikaya | Email: hannah.kikaya@ hmpg.co.za MANAGING EDITOR Ingrid Nye TECHNICAL EDITORS Emma Buchanan Paula van der Bijl NEWS EDITOR Chris Bateman | Email: chrisb@hmpg.co.za PRODUCTION MANAGER (CMC) Emma Jane Couzens DTP & DESIGN (CMC) Carl Sampson HEAD OF SALES AND MARKETING Diane Smith | Tel. 012 481 2069 Email: dianes@samedical.org JOURNAL ADVERTISING Charles William Duke Benru de Jager Reneé van der Ryst PROFESSIONAL ADVERTISING Ladine van Heerden | Tel. 012 481 2121 Email: ladinev@samedical.org ONLINE SUPPORT Gertrude Fani | Tel. 072 463 2159 Email: publishing@hmpg.co.za
EDITORIALS 451
Minimising the ‘cost’ of laparoscopic cholecystectomy S R Thomson, M D Smith
452
The management of burns begins at home D Wood
453
Paediatric dental sedation: Will your child return home unharmed? B J S Diedericks
FINANCE Tshepiso Mokoena
RESEARCH 454
A cost analysis of operative repair of major laparoscopic bile duct injuries S Hofmeyr, J E J Krige, P C Bornman, S J Beningfield
457
Prehospital cooling of severe burns: Experience of the Emergency Department at Edendale Hospital, KwaZulu-Natal, South Africa D Fiandeiro, J Govindsamy, R C Maharaj
461
Paediatric dental chair sedation: An audit of current practice in Gauteng, South Africa F Bham, H Perrie, J Scribante, C-A Lee
465
The South African Surgical Outcomes Study: A 7-day prospective observational cohort study* B M Biccard, T E Madiba, on behalf of the South African Surgical Outcomes Study investigators
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ASSOCIATE EDITORS Q Abdool Karim, A Dhai, N Khumalo, R C Pattinson, A Rothberg, A A Stulting, J Surka, B Taylor, M Blockman
June 2015, Vol. 105, No. 6
HMPG BOARD OF DIRECTORS Prof. M Lukhele (Chair), Dr M R Abbas, Dr M J Grootboom, Mrs H Kikaya, Adv. Y Lemmer, Prof. E L Mazwai, Dr M Mbokota, Mr G Steyn, Dr G Wolvaardt Production and distribution services supplied and managed by Media Outsourcing, a wholly owned subsidiary of Cape Media Corporation. Tel. 021 681 7000 ISSN 0256-9574 Publisher website: www.hmpg.co.za SAMA website: www.samedical.org Journal website: www.samj.org.za
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the affordable5 endurance Ace-inhibitor For further product information contact PHARMA DYNAMICS P O Box 30958 Tokai Cape Town 7966 Tel 021 707 7000 Fax 021 701 5898 Email info@pharmadynamics.co.za CUSTOMER CARE LINE 0860 PHARMA (742 762) www.pharmadynamics.co.za Pearinda 4. Each tablet contains 4 mg perindopril tert-butylamine. Reg. No.: RSA S3 41/7.1.3/0649. NAM NS2 10/7.1.3/0476. Pearinda 8. Each tablet contains 8 mg perindopril tert-butylamine. Reg. No.: RSA S3 41/7.1.3/0650. NAM NS2 10/7.1.3/0477. For full prescribing information, refer to the package insert approved by the Medicines Control Council, April 2009. Pearinda Plus 4. Each tablet contains 4 mg perindopril tert-butylamine and 1,25 mg indapamide. Reg. No.: RSA S3 41/7.1.3/0633. NAM NS2 10/7.1.3/0611. For full prescribing information, refer to the package insert approved by the Medicines Control Council, April 2010. 1) The EUROPA study Investigators. “Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: randomized, double-blind, placebo-controlled, multicentre trial (the EUROPA study)”. The Lancet 2003;362:782788. 2) The PREAMI study Investigators. “Effects of angiotensin-converting enzyme inhibition with perindopril on left ventricular remodelling and clinical outcome. Results of the randomized perindopril and remodelling in elderly with acute myocardial infarction (PREAMI) study”. Arch Intern Med 2006;166:659-666. 3) PROGRESS Collaborative Group. “Randomised trial of a perindopril-based blood-pressure-lowering regimen among 6105 individuals with previous stroke or transient ischaemic attack”. The Lancet 2001;358:1033-41. 4) Guerin AP, et al. “Impact of Aortic Stiffness Attenuation on Survival of Patients in End-Stage Renal Failure”. Circulation 2001;103;987-992. 5) Department of Health website http//www.health.gov.za – Accessed on 26/03/2015. PAE178/06/2015.
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The impact of acute preoperative beta-blockade on perioperative cardiac morbidity and all-cause mortality in hypertensive South African vascular surgery patients* Y Moodley, B M Biccard
480
Granulomas at initial diagnosis of Crohn’s disease signal a poor outcome* G Watermeyer, S R Thomson
484
Waiting times for prostate cancer diagnosis in KwaZulu-Natal, South Africa* K Singh, E H Abdel Goad, S S Ramklass
487
The appropriateness of preoperative blood testing: A retrospective evaluation and cost analysis* H E Buley, D Bishop, R Rodseth
491
Analysis of referrals and triage patterns in a South African metropolitan adult intensive care service* K Gordon, N Allorto, R Wise
496
Outcomes of vitrectomy for advanced diabetic retinopathy at Groote Schuur Hospital, Cape Town, South Africa* J C Rice, J Steffen
CONTINUING MEDICAL EDUCATION
500
Trauma care – the Eastern Cape story J John, W Matshoba
501
INTRODUCTION Introduction to algorithms for managing the common trauma patient L Wallis
502
ALGORITHMS Algorithms for managing the common trauma patient J John
*Full article available online only.
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Hyenas and vultures view their next meal. Photo: Susan Flegg
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June 2015, Vol. 105, No. 6
GUEST EDITORIAL
A good complaints system Healthcare professionals should accept that mis takes are an inevitable part of clinical practice. Despite what patients may think – and many expect doctors to be infallible, and the healthcare system to be flawless – medicine by its very nature is risky. Accepting that things will not always go to plan, and that patients will complain, should make doctors think about developing their own system for handling complaints. While complaints often provide invaluable feedback on an individual’s performance, they also offer dissatisfied patients an opportunity to air their views. Even if a complaint is without justification, a complaints system that works well will at least allow an individual to respond and give their account of the incident. This can help doctors avoid further, potentially more difficult, avenues of investigation such as by the Health Professions Council of South Africa (HPCSA) or a clinical negligence claim. Having a good-quality, standardised process for complaints handling, with well-trained staff in place, can help to avoid further anxiety for both parties. It is much better to embrace a complaint than to evade it. With understanding, empathy, action and honesty, a strong complaints handling system can benefit everyone involved. Solutions to the growing number and severity of clinical negligence claims come in various forms. A key step in avoiding litigation is understanding what dissatisfied patients actually want following an adverse outcome. One way of doing this may be to establish a strong and comprehensive complaints system. While a healthcare professional’s natural inclination when an adverse outcome occurs may be to hide, having a good complaints system in place can offer benefits that prevent an individual from facing criticism. Ignoring complaints or failing to provide the means for patients to complain may simply force them down alternative routes, either by making a complaint to the HPCSA or by instructing an attorney to begin a claim.
Why do patients sue?
To help support the argument for a good complaints system, it is important to understand why patients are aggrieved with their care, and what leads them to sue. While financial compensation is an understandable goal in cases of severe injuries, most other patients primarily want answers, explanations and reassurance. They often seek a sense of closure that is undoubtedly provided by a full and honest clarification of what happened and why it went wrong. This is usually accompanied by a sincere apology, which in itself is not an admission of liability. In many cases, patients may only want acknowledgement that a complication has occurred, and there is widespread literature supporting this view. A study from Taiwan found that an emotional need for comfort and the sense of ‘being cared for’ was a key factor for patients and their families suing doctors,[1] while a study published in The Lancet found that ‘Patients taking legal action wanted greater honesty, an appreciation of the severity of the trauma they had suffered, and assurances that lessons had been learnt from their experiences.’ The study surveyed 227 patients and their families who had instructed clinical negligence solicitors.[2]
Alternative options
Without the opportunity to make a complaint, a dissatisfied patient is likely to turn to other options. Patients may look to take the easiest route to expressing their dissatisfaction, but the options available to them are anything but easy: usually, these are either reporting a
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doctor to the HPCSA or instructing an attorney to make a claim for clinical negligence. Both processes are daunting in terms of the considerable length of time they can take, with the added emotional stress this brings for both doctor and patient. Neither is in the best interests of the doctor, nor will either option really give the patient the closure they want, unless their aim is obtaining financial compensation for a severe injury. The HPCSA is bound by statute to investigate a complaint in the context of professional misconduct – it is not investigating the complaint, it is investigating a doctor’s fitness to practise. Similarly, a law firm’s interest is not in resolving a complaint – its interest is in terms of redress, and the focus will therefore be on establishing negligence. Yet many complaints have nothing to do with negligence. Neither approach is the quickest or the most satisfying route to resolution for either doctor or patient.
What makes a good complaints system?
When something goes wrong, the ensuing patient dissatisfaction has to be managed. The best way to do this is through a feedback system that allows the patient to deal with their dissatisfaction ‘in-house’, between themselves and the provider.[1] A good complaints system: • Understands the patient’s dissatisfaction • Sees the options that will resolve matters for the patient • Tries to seek joint resolution. A good complaints system is also able to suitably record and respond to a complaint in a way that demonstrates learning and improvement – a learning culture rather than an adversarial culture. This allows for incidents to be reported as adverse outcomes and for the development of strategies to prevent similar errors occurring in the future. Patients should be given the opportunity to voice their side of the story, to talk through the impact the incident has had on them, and to get the closure they need. A good system should also give healthcare professionals the chance to explain their side of the story in a nonadversarial environment, without fear of retribution, in an open and enquiring way. There are a number of principles of excellent complaints handling:[3] • Recognition of the complaint, so the patient feels acknowledged • Understanding of why the patient is dissatisfied • Showing empathy to demonstrate that the system and the doctor understands the emotional impact on the patient • Effective action – a speed of response that is commensurate with the nature of the complaint; while a quick response can be satisfying for the patient, the complaint must be thoroughly investigated so that the patient can see that the response is not being made in haste, with speculation in place of insight • Benefit for the patient – this could be an explanation, redress, commitment to get it right next time or reassurance that the problem will be rectified, to show that people have learned from the incident • Honesty and transparency, so that the patient can see an open profession. It may also be helpful for an impartial third party to intervene to mediate a complaint, if a patient is unable to resolve their concerns directly with a healthcare professional.[4] Mediation can be a successful way to bring two parties together, and there are numerous professional organisations in South Africa that offer an impartial mediation service.
June 2015, Vol. 105, No. 6
GUEST EDITORIAL
For an example of a complaints system, read about COPIC on p. 436.
Conclusion
1. Chiu YC. What drives patients to sue doctors? The role of cultural factors in the pursuit of malpractice claims in Taiwan. Soc Sci Med 2010;71(4):702-707. [http://dx.doi.org/10.1016/j. socscimed.2010.04.040] 2. Vincent C, Young M, Phillips A. Why do people sue doctors – a study of patients and relatives taking legal action. Lancet 1994;343(8913):1609-1613. [http://dx.doi.org/10.1016/S01406736(94)93062-7] 3. Tiernan J. The importance of complaints handling. Hong Kong Dent J 2006;3 (2):134-136. 4. Walters J. Mediation – an alternative to litigation in medical malpractice. S Afr Med J 2014;104(11):717718. [http://dx.doi.org/10.7196/SAMJ.8851] 5. Johnston R. Service failure and recovery: Impact, attributes and process. Advances in Services Marketing and Management: Research and Practice 1995;4:211-228.
According to Johnston,[5] an expert on customer service delivery, successful handling of complaints can build patient ‘loyalty’ and make them less likely to complain in the future. In this sense, patients are viewed as customers, and as most complaints are about minor service issues the relationship between doctor and patient does take on a customer service nature. More importantly, a good complaints handling service can give patients what they need after an adverse outcome in a much less painful manner than, for example, litigation. Surely this is in everyone’s best interests?
S Afr Med J 2015;105(6):425-426. DOI:10.7196/SAMJ.9358
Graham Howarth Head of Medical Services in Africa, Medical Protection Society, Victoria House, 2 Victoria Place, Leeds, UK graham.howarth@mps.org.uk
Gareth Gillespie Communications Manager, Medical Protection Society, Victoria House, 2 Victoria Place, Leeds, UK
John Tiernan Executive Director, Member Engagement Division, Medical Protection Society, Victoria House, 2 Victoria Place, Leeds, UK
Pieter Carstens Head of the Department of Public Law, Faculty of Law, University of Pretoria, South Africa
This month in the SAMJ ... Bruce Biccard*† is an anaesthesiologist and Honorary Associate Professor at the University of KwaZulu-Natal. His principal area of practice is vascular anaesthesia, and his research interests include the epidemiology of cardiovascular disease, perioperative cardiovascular risk prediction and risk modification, perioperative medicine and surgical outcomes. He is an active member of the Perioperative Research Group, Department of Anaesthesiology and Critical Care, Nelson R Mandela School of Medicine, where national and international collaborative perioperative outcomes research is conducted. He is an active proponent of collaborative research to improve public health. * Biccard BM, Madiba TE, on behalf of the Perioperative Research Group. The South African Surgical Outcomes Study: A 7-day prospective observational cohort study. S Afr Med J 2015;105(6):465-475. [http://dx.doi.org/10.7196/SAMJ.9435] †
Moodley Y, Biccard BM. The impact of acute preoperative beta-blockade on perioperative cardiac morbidity and all-cause mortality in hypertensive South African vascular surgery patients. S Afr Med J 2015;105(6):476-479. [http://dx.doi.org/10.7196/SAMJ.8856]
Daniel Fiandeiro,* specialist in emergency medicine, is a graduate of the University of the Witwatersrand medical school. Currently working at Lister Hospital in the UK, he is an ATLS and level one ultrasound instructor with diplomas in emergency care and anaesthetics. He has a special interest in trauma and the prehospital and emergency care of burns. * Fiandeiro D, Govindsamy J, Maharaj RC. Prehospital cooling of severe burns: Experience of the Emergency Department at Edendale Hospital, KwaZulu-Natal, South Africa. S Afr Med J 2015;105(6):457-460. [http://dx.doi.org/10.7196/SAMJ.8705]
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June 2015, Vol. 105, No. 6
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EDITOR’S CHOICE
CME: Trauma
Trauma is a major source of mortality and morbidity in South Africa (SA). An estimated 48 000 South Africans die as a result of trauma annually, with a further 3.5 million needing treatment. SA’s overall injury death rate is nearly twice the global average. Rising levels of poverty and unemployment, limited access to education, alcohol and drug abuse, widespread access to firearms and other weapons, exposure to violence in childhood and a weak culture of enforcement are just few of the many factors contributing to this carnage. Having campaigns and strategies in place to curb the attitude of violence and address the underlying contributing factors is vital. The rates of both transport accident-related (11% v. 11.6%) and assaultrelated deaths (10.2% v. 15.7%) as a percentage of total non-natural deaths in SA’s Eastern Cape Province, for example, are worryingly higher than the national average, which is in keeping with the high levels of poverty in the province. However, the ability to provide quality care to the victims of these injuries is just as important. It is the latter that poses the biggest challenge for the Eastern Cape. While the algorithms in this month’s CME were developed in the Eastern Cape, the trauma that they aim to manage is apparent throughout the country. A junior medical officer and a consultant working in the surgical disciplines in the East London Hospital Complex have produced the Surgery Survival Guide. It is from the pages of this 200-page handbook that the algorithms are taken. They are broadly applicable, and should serve as quick references for those working in situations where trauma is common.
A good complaints system
The practice of medicine is a risky business, and the expectations of the public regarding the professional and ethical standards of their doctors are higher than ever before. Errors and mistakes are an unavoidable part of professional practice, despite the best of intentions on the part of doctors. A dissatisfied patient, lacking the opportunity to make a complaint, is likely to report a doctor to the Health Professions Council of South Africa, or instruct attorneys to make a claim for clinical negligence. Howarth et al.[1] suggest that a key step in avoiding litigation is the establishment of a good complaints system, and offer the ingredients of such a system while outlining the principles of excellent complaints handling. See also ‘SAMA pitches in to help victims of medical negligence’.[2]
Surgical outcomes in SA
The South African Surgical Outcomes Study,[3] a 7-day prospective observational cohort study contributed to by surgeons from across the country, sought to investigate perioperative mortality and need for critical care admission in patients ≥16 years of age undergoing inpatient non-cardiac surgery between 19 and 26 May 2014 at 50 public sector, government-funded hospitals. In the context of the fact that, according to the just-released Lancet Commission on Global Surgery report[4] (Martin Smith, co-author of the editorial on p. 451, having served as a commissioner), 5 billion people in the world (and 93% in sub-Saharan Africa) cannot obtain basic surgical care (see Fig. 2[4]), this extensive survey paints a happy picture for SA. However, there is no room for complacency (see Fig. 10[4]), which suggests the necessary future scale-up to meet projected 2030 requirements. While access to surgical care is essential for reduction of mortality and morbidity from surgical conditions, most patients in SA’s public sector hospitals require urgent and emergency surgery, which is strongly associated with mortality and unplanned critical care admissions. Non-communicable diseases have a larger proportional contribution to mortality than infections
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and injuries. Significantly, HIV infection, although the most common comorbidity, was not associated with in-hospital mortality.
What do major laparoscopic bile duct injuries cost to repair?
In their cost analysis of operative repair of major laparoscopic bile duct injuries, Hofmeyr et al.[5] calculate the total in-hospital cost of surgical repair of major bile duct injuries sustained during laparoscopic cholecystectomy. The cohort of 44 patients, all of whom had major bile duct injuries repaired by Roux-en-Y hepaticojejunostomy, is unique in respect of the number of patients evaluated. The implications of a major bile duct injury can be profound, with the spectre of protracted hospitalisation and invasive investigations, the anxiety of major reconstructive surgery, a lengthy rehabilitation period, decreased quality of life, loss of income and, in some cases (particularly in the present SA medicolegal environment – see above), prolonged and unpleasant litigation. The financial burden implicit in injury management (the cost of repair of a major laparoscopic bile duct injury is substantial, averaging ZAR215 711 (range ZAR68 764 - 980 830) – a reflection of prolonged admission to hospital, complex surgical intervention, and intensive imaging requirements) and the consequences for the patient are significant. Thomson and Smith[6] also stress in an accompanying editorial that the costs of the repair are not the only financial costs. Medicolegal costs can be considerable, and there are substantial non-fiscal ‘costs’ for the patient, the ‘injuring’ surgeon and their families. Prevention must remain the top priority during laparoscopic cholecystectomy.[5,6]
The management of burns begins at home
Burns are one of the leading causes of disability-adjusted life years lost, with approximately 3.2% of South Africans suffering thermal injuries each year. The timeous access of burns patients to appropriate medical care is emphasised in an article describing the Edendale Hospital Emergency Department experience of prehospital cooling of severe burns[7] and an accompanying editorial.[8] Children are at particular risk of hot-water scalds and burns in household accidents involving cooking pots, open fires and stoves. Fortunately, nine out of ten hot-water burn injuries are minor, and first-aid measures are effective – application of cool (not iced) water to burns for 10 - 20 minutes early after the injury affords relief of pain and limits tissue necrosis, with improved healing and reduced complications. Even cooling up to 3 hours after a burn has been shown to be beneficial. Of great concern is the number of non-accidental burn injuries (NAIs) in children. Some 5% of burns in children in KwaZulu-Natal are NAIs, resulting primarily from immersion of the child’s limbs and buttocks in hot water.
Non-alcohol-related Wernicke’s encephalopathy (WE)
In their report of three cases of non-alcohol-related WE, Antel et al.[9] remind us that WE may not be a sign of alcoholism, but may represent thiamine deficiency secondary to persistent vomiting. WE is always a medical emergency, and non-alcohol-related WE tends to be more catastrophic in onset and less likely to present with the classic features. It may be seen in the malnourished, in the elderly and in chronic illness.[10] All high-risk individuals presenting to the emergency room should receive 200 mg parenteral thiamine before any administration of glucose. Thereafter the recommendation is intravenous thiamine (200 - 500 mg) given in 100 ml normal saline or 5% glucose over 30 minutes, three times daily for 3 days, followed by
June 2015, Vol. 105, No. 6
EDITOR’S CHOICE
200 mg three times daily until the patient has improved substantially, when 100 mg daily orally will suffice.
Authors and readers please note
With this June SAMJ, we are moving to a policy of publishing most, if not all, research papers in full online, with their abstracts – which if artfully written should ‘tell the whole story’ of the research and whet the appetites of interested readers[11] – in the print edition. The rationale is partly cost-containment and partly the need to move into the digital space, as with so much publishing today, in the knowledge that our young readership is impatient of print, preferring to access their reading on smart phones and tablets. JS 1. Howarth G, Tiernan J, Gillespie G, Carstens P. A good complaints system. S Afr Med J 2015;105(6):425426. [http://dx.doi.org/10.7196/SAMJ.9358]
2. Bateman C. SAMA pitches in to help victims of medical negligence. S Afr Med J 2015;105(5):337-338. [http://dx.doi.org/10.7196/SAMJ.9683] 3. Biccard BM, Madiba TE, on behalf of the South African Surgical Outcomes Study investigators. The South African Surgical Outcomes Study: A 7-day prospective observational cohort study. S Afr Med J 2015;105(6):465-475. [http://dx.doi.org/10.7196/SAMJ.9435] 4. Meara, JG, Leather, AJM, Hagander, L, et al. Global surgery 2030: Evidence and solutions for achieving health, welfare, and economic development. Lancet 2015 (published online 27 April 2015). [http:// dx.doi.org/10.1016/S0140-6736(15)60160-X] 5. Hofmeyr S, Krige JEJ, Bornman PC, Beningfield SJ. A cost analysis of operative repair of major laparoscopic bile duct injuries. S Afr Med J 2015;105(6):454-457. [http://dx.doi.org/10.7196/ SAMJ.9038] 6. Thomson SR, Smith MD. Minimising the ‘cost’ of laparoscopic cholecystectomy. S Afr Med J 2015;105(6):451-452. [http://dx.doi.org/10.7196/SAMJ.9791] 7. Fiandeiro D, Govindsamy J, Maharaj RC. Prehospital cooling of severe burns: Experience of the Emergency Department at Edendale Hospital, KwaZulu-Natal, South Africa. S Afr Med J 2015;105(6):457-460. [http://dx.doi.org/10.7196/SAMJ.8705] 8. Wood D. Management of burns begins at home. S Afr Med J 2015;105(6):452. [http://dx.doi. org/10.7196/SAMJ.9627] 9. Antel K, Singh N, Chisholm B, Heckmann JM. Encephalopathy after persistent vomiting: Three cases of non-alcohol related Wernicke’s encephalopathy. S Afr Med J 2015;105(6):442-443. [http://dx.doi. org/10.7196/SAMJ.9299] 10. Wikipedia. Wernicke’s encephalopathy. http://en.wikipedia.org/wiki/Wernicke’s_encephalopathy (accessed 13 April 2015). 11. Seggie J. On getting published in the SAMJ. S Afr Med J 2015;105(2):77-78. [http://dx.doi.org/10.7196/ SAMJ.9348]
South African Thoracic Society
ANNUAL CONFERENCE
7-10 August 2015 CAPE TOWN | South Africa
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CORRESPONDENCE
Patient satisfaction with emergency departments
To the Editor: Thе Nаtiоnаl Dеpаrtmеnt оf Hеаlth clеаrly stаtеs its missiоn оbjеctivе ‘tо imprоvе quаlity оf cаrе оf аll lеvеls оf thе hеаlth systеm is a priоrity’.[1] Thе Dеpаrtmеnt аlsо аims tо ‘imprоvе thе оvеrаll еfficiеncy оf thе hеаlth cаrе dеlivеry systеm’. Thе kеy wоrds аrе imprоvеmеnt, quаlity аnd еfficiеncy. So, are we all striving towards this objective? Are we all constantly trying to improve the level of service we offer to our patients and to improve their level of satisfaction? Hоw dоes a healthcare practitioner knоw whеn they аrе sаtisfying their pаtiеnts’ nееds аnd thеir pеrcеptiоn оf gооd hеаlthcаrе? Thе businеss wоrld, еspеciаlly thе sеrvicе industry, dоеs this еffеctivеly by rоutinеly cоnducting custоmеr sаtisfаctiоn survеys, thereby idеntifying аrеаs that аrе lаcking. Healthcare practitioners and healthcare institutions should be doing the same. Measurement of pаtiеnt pеrcеptiоn, nо mаttеr hоw difficult, cаn bе imprоvеd viа cоntinuоusly doing pаtiеnt-оriеntatеd survеys tо fully undеrstаnd, еffеctivеly mаnаgе аnd thеn еxcееd patients’ еxpеctаtiоns as thе ultimаtе gоаl. In 2005, а survеy оf 40 000 hоusеhоlds shоwеd thаt 65% оf rеspоn dеnts idеntifiеd thаt bоth cаrе аnd cоmpаssiоn аrе mоrе impоrtаnt thаn tеchnicаl prоficiеncy whеn rеcеiving mеdicаl cаrе.[2] Pоwеr аnd аssоciаtеs further cоnductеd а survey which shоwеd thаt ‘sаtisfаctiоn with thе hоspitаl еxpеriеncе wаs drivеn (in оrdеr оf impоrtаncе) by dignity аnd rеspеct, spееd аnd еfficiеncy, cоmfоrt, infоrmаtiоn, аnd cоmmunicаtiоn аnd еmоtiоnаl suppоrt’.[2] In South Africa (SA), thеrе hаs bееn incrеаsing cоncеrn rеgаrding thе mоunting prеssurеs оn еmergency departments (EDs). Frеquеnt mеdiа rеpоrts dоcumеnt incrеаsеs in wаiting timеs, оvеrcrоwding аnd the resulting cоmprоmisеd quаlity оf cаrе in ЕDs. We recently conducted a survey to determine what the expectations are of a local patient population аttеnding а public sеctоr ЕD and how happy they are with their care. As wаiting timе is а kеy fаctоr in pаtiеnt sаtisfаctiоn in ЕDs, satisfaction predictably dipped the longer the patient waited. The total time spent in the ED averaged 295, 386 and 451 minutes depending upon the acuity of illness (for orange, yellow and green category patients, respectively), compared with the average time of 247 minutes for all category patients across the USA in 2010.[3] One may be forgiven for thinking that there is not much we can do about the situation in our under-resourced, overcrowded environment, but there are measures that can be implemented. One еffеctivе measure tо аchiеvе pаtiеnt satisfaction is tо mаnаgе pеrcеptiоns аnd еxpеctаtiоns оf wаiting timе. Studiеs hаvе shоwn thаt if pаtiеnts аrе bеing infоrmеd аbоut thе wаiting timе, thеy аrе mоrе sаtisfiеd. It is also important to constantly educate our patients that their prolonged wait at a tertiary or secondary institution could have been avoided had they attended a more appropriate clinic or primary healthcare facility. It is interesting to note that while green-category patients spent an average of 271 minutes waiting to be attended to, the attending doctor required only an average of 24 minutes to take the history, investigate, diagnose and treat the patient. This is surely an argument for instituting fast-tracking of patients, which can be accomplished in a number of ways, two of which have been successfully implemented worldwide. We refer to the introduction of minor injury units
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(MIUs) in busy EDs. These MIUs can be staffed by advanced nurse practitioners (ANPs), physician assistants (PAs) or clincal associates. An ANP is defined as a person who focuses on primary care, health assessment, diagnosis and treatment. A PA is North America’s equivalent of the ANP. In SA, we have no ANP or PA programme. Heeding this call, the University of the Witwatersrand has instituted the 3-year Clinical Associate Programme, designed to qualify ANPs or PAs. MIUs staffed by ANPs and PAs hаvе bееn been еvаluаtеd very fаvоurаbly, with pаtiеnts stаting incrеаsеd sаtisfаctiоn with the quаlity оf sеrvicе.[4,5] From the respondents in our survey, frequent negative comments centred around the level of comfort and security in the waiting room. Cleanliness of the patient toilets also featured prominently. This highlights the point raised earlier that simple, seemingly trivial, measures can vastly improve patient satisfaction. When previous quality surveys were done, whether а pаtiеnt spеnt оnе hоur оr fоur hоurs in thе ED, thоsе whо rаtеd thе wаiting rооm аs ‘vеry pооr’ in cоmfоrt hаd drаmаticаlly lоwеr оvеrаll sаtisfаctiоn with thеir visit thаn thоsе whо rаtеd thе cоmfоrt оf thе wаiting rооm аs ‘vеry gооd’. Hоspitаls cаn аnаlysе thеir pаtiеnts’ cоmmеnts tо find wаys tо imprоvе thе cоmfоrt lеvеl. Simplе interventions such аs rеpаiring thе аir cоnditiоning оr rеplаcing thе chаirs mаy hаvе а nоticеаblе еffеct оn pаtiеnts’ pеrcеptiоns оf thе ЕD. A benefit of a patient perception study is that it is simple to perform and easily reproducible in other EDs in different localities to further understand patient needs, as patient requirements will differ in different sociodemographic localities. Similar surveys can also be used to monitor progress in EDs as we strive towards enhancing patient care. The challenges of prolonged waiting times, under-resourced and overcrowded EDs are intense. However, patients are willing to wait for care as long as they are kept informed about the waiting time and are received by empathetic attending healthcare workers. There is a paucity of research looking at qualitative aspects of patient care in SA – more studies need to be done as we strive towards providing optimal care. Zeyn Mahomed
Emergency Physician, Far East Rand Hospital, and Division of Emergency Medicine, University of the Witwatersrand, Johannesburg, South Africa zeynmahomed@gmail.com
Lee Wallis
Head of the Division of Emergency Medicine, University of Cape Town and Stellenbosch University, Tygerberg, Cape Town, South Africa
Feroza Motara
Division of Emergency Medicine, University of the Witwatersrand, Johannesburg, South Africa 1. Dеpаrtmеnt оf Hеаlth, Sоuth Аfricа. Strаtеgic Plаn. http://www.health-e.org.za/2014/09/25/reportdepartment-health-strategic-plan-201415-20189/ (accessed 13 May 2015) 2. J. D. Power and Associates. The distinguished hospital program.(accessed 13 May 2015). 3. Press Ganey and Associates. The 2010 Emergency Department Pulse Report. www.pressganey.com (accessed 13 May 2015). 4. Bеаlеs J, Bаkеr B. Minоr injuriеs unit: Expаnding thе scоpе оf еmеrgеncy prоvisiоn. Accid Emerg Nurs 1995;3(2):65-67. [http://dx.doi.org/10.1016/0965-2302(95)90085-3] 5. Bеаlеs J. Innоvаtiоn in еmеrgеncy mаnаgеmеnt: Estаblishing а nursе prаctitiоnеr-run minоr injuriеs/primаry cаrе unit. Accid Emerg Nurs 1997;5(2):71-75. [http://dx.doi.org/10.1016/s09652302(97)90082-5]
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Stellenbosch University: Africa’s first WHO Bioethics Collaborating Centre Stellenbosch University (SU)’s Centre for Medical Ethics and Law became Africa’s first World Health Organization (WHO) Bio ethics Collaborating Centre in April this year, after several years of working with the global body in vital areas such as vaccine policies, bio-banking and research ethics.
Prof. Anton van Niekerk, Director of Stellenbosch University’s Centre for Applied Ethics, Prof. Keymanthri Moodley, Director of the SU Centre for Medical Ethics and Law, and Dr Andreas Reis of the World Health Organization.
It joins a prestigious international network of university bioethics centres in Toronto, New York, Zurich, Singapore, Miami and Melbourne which, among other things, informs the WHO’s ethical understanding and response to global humanitarian crises such as the recent Ebola outbreak in West Africa. The collaboration will be renewable in 2019, with the current agreement being to cover ethical issues in neurological science and mental health (neuroimaging and dementia being of growing importance), and advising and developing guidelines on bio-banking and research ethics (with ongoing capacity-building workshops for the African region). The SU Centre has already played a pivotal role in developing WHO guidelines on ethical issues in public health surveillance. It will also monitor new issues in the local field as they arise. Prof. Andreas Reis, strategy ambassador for strengthening and developing the WHO’s regional institutional capacity and carrying
out its mandated projects, said that the Ebola outbreak powerfully demonstrated the inherently global nature of ethics and the interconnectedness of all countries. ‘We can learn a lot from SA’s concept of Ubuntu – we’ll only succeed globally if we build mutually beneficial partnerships.’ He said that the Centre for Medical Ethics and Law, established in 2003, was one of the oldest and most prestigious in Africa, having built an excellent global reputation for empirical and conceptual research and medical ethics teaching, including a postgraduate diploma in research ethics, funded by the US National Institutes of Health. Prof. Jimmy Volmink, Dean in the Faculty of Medicine and Health Sciences, said that SU had a ‘long and proud history’ of partnership with the WHO, stretching over many decades. Its academic staff served on various WHO advisory boards and on several working groups, the most prominent being paediatric and drug-resistant tuberculosis (TB). Prof. Keymanthri Moodley, Director of the SU Centre for Medical Ethics and Law, was one of two SU academics in the WHO’s Strategic Advisory Group of Experts (SAGE) on immunisation during humanitarian crises, and was currently part of the SAGE working group on Ebola vaccines. Other SU work that guided WHO policy formulation included the ongoing development of an HIV vaccine, health systems strengthening, prevention of mother-to-child HIV transmission and adherence to antiretroviral and TB drugs. Volmink singled out philosophy professor Anton van Niekerk, Director of SU’s Centre for Applied Ethics, as ‘one of the fathers of bioethics’ in SA, saying he played a leading role in teaching and mentoring several clinicians/bioethicists who contribute to teaching in the Centre. Van Niekerk told the gathering that bioethics had (belatedly) come a long way since Chris Barnard’s heart transplant, which would have ‘failed dismally’ to clear today’s ethical hurdles (i.e. the definition of death). ‘Bioethics was not taken seriously before the 1980s [in SA]; the attitude was that it was important, but taught by the bedside with no serious need for the philosophical underpinnings – you could get around it by simply making it a practical subject.’ The pivotal and founding local event for bioethics in SA was the death of Steve Biko in December 1977.
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Together with the Soweto uprising in June 1976, these deaths made it clear that the rhetoric of government leaders about the intended justice of the homeland system and other alleged justifications for apartheid were bogus and that the system was morally corrupt with its demise ‘a mere matter of time’. The Biko affair highlighted the importance of a moral orientation in the practice of medicine and directly contributed to a reorganisation of the institutionalised medical profession in SA. Greater attention to ethical responsibilities towards prisoners, detainees and hunger strikers ensued, while the public confession of guilt by the district surgeon who bore major responsibility for Biko’s medical care emphasised the need to maintain professional independence in the face of state security and other coercive pressures. Biko’s death highlighted the depths to which a society could sink when gross violations of human rights became commonplace, and illustrated the social and political impact that a severe violation of medical morals had on SA society. Van Niekerk said the teaching of bio ethics, while not progressing equally across medical faculties, had increased profoundly in the past 20 years, particularly since it was introduced into healthcare worker undergraduate education in the late 1990s. HIV/AIDS had raised a ‘host’ of bioethical issues, not to mention TB and malaria, making SA a leading international destination for biomedical researchers. He paid tribute to the contribution of Ethics SA’s Prof. Willem Landman and his empirical research on the state of the medical profession in SA and the appalling conditions in several major hospitals, and said that Ethics SA had also changed the face of abortion in SA by helping introduce the Termination of Pregnancy Act (1996), which remained one of the most liberal laws in the world. The draft law on assisted death, tabled by the Law Commission in Parliament in 1998, was shelved by government but still contained ‘some remarkable suggestions’ which would have to be confronted ‘sooner or later’. The National Research Ethics Council had produced outstanding and long-awaited revised guidelines for ethical research that had been ‘signed off ’ by the health minister and his director-general, now probably due for publication next year. Moodley said her journey to Director of the Centre began in 1997 when she was a
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new consultant to Prof. Pierre de Villiers, then head of the Department of Family Medicine at SU. ‘He gave me a huge pile of folders and told me to prepare two ethics lectures for fifth-year medical students, unschooled as I was in medical ethics. I took it on as a challenge.’ By the following year she realised she needed ‘much greater depth of knowledge in ethics’ and studied philosophy under Van Niekerk, ‘thinking about value systems and morality’, before going to Columbia University in New York
as a Fogarty Fellow. In the midst of the Twin Towers 9/11 tragedy, she studied public health ethics with Prof. Ron Bayer (who now chairs the global network of WHO collaborating centres in bioethics). He encouraged her to start working on her doctorate. Upon her return to SA she approached Prof. Wynand van der Merwe, then Dean of SU’s Faculty of Medicine, suggesting the establishment of a SU Centre for Bioethics. He and Prof. Barney de Villiers (now deceased) made the Centre into a reality. Together with Profs Willie
Pienaar and Sharon Kling, Moodley has built a strong and dynamic undergraduate ethics programme, with several fifth-year medical students today regarding their ethics block as ‘among the most stimulating’ because it teaches them ‘to think and challenge’. Chris Bateman chrisb@hmpg.co.za S Afr Med J 2015;105(6):430-431. DOI:10.7196/SAMJ.9748
Healthcare workers baulk at caring for contagious patients Globally, healthcare workers (HCWs) are reluctant to care for highly infectious patients, with over half surveyed in the USA saying it was acceptable not to pitch up for work during an outbreak of (for example) avian flu, World Health Organization (WHO) surveys show. Dr Andreas Reis, strategy ambassador for strengthening and developing the WHO’s regional institutional capacity and carrying out its mandated projects, said there were widely differing country attitudes to the vexed question of HCWs exposing themselves to high-risk infection. He was speaking after a ceremony on the Tygerberg campus of Stellenbosch University designating its Centre for Medical Ethics and Law as a WHO Collaborating Centre. Reis said that in Taiwan, China, about 57% of nurses indicated that they were willing to care for patients infected with avian flu, the perception of the importance of their role being the most influential factor. However, in Germany this figure rose to 72%, while just 28% agreed that it would be professionally acceptable to abandon their workplace in order to protect themselves and their families. Most German HCWs (58%) did not believe that the decision to report to work during a pandemic should be left to the individual HCW, yet 77% of them disagreed that HCWs should be dismissed for not reporting to work. In Canada, doctors who wanted to abandon posts during the 2003 outbreak of severe acute respiratory syndrome (SARS) in Toronto faced threats of ostracism. Reis said that the American Nurses’ Association’s advice to HCWs was ‘to engage in critical thinking and ethical analysis’. Arguments for a moral obligation included an HCW’s ability to provide care being greater than that of the public, that they freely chose
their profession knowing it had inherent risks, and that there was an unspoken social contract. However, limits and conflicts included the dual role of caring for oneself and one’s family and the balance of immediate benefits to individual patients with the ability to care for patients in the future. Governments and employers had a reciprocal obligation to minimise the risk to HCWs. These included ensuring adequate infection control systems, providing preventive measures (e.g. pharmaceuticals, personal protective equipment), and taking a stand on the thorny issue of whether HCWs should have preferential access to experimental drugs, or receive priority treatment, prophylaxis or vaccines. Yet another obligation included putting in place death and disability benefits for HCWs.
Human resources key to any humanitarian response
Reis said that sufficient human resources formed the foundation of any effective response to a humanitarian crisis. The 2013 WHO report ‘A Universal Truth: No health without a workforce’ showed that there was a global shortage of almost 7.2 million doctors, midwives and nurses, plus healthcare support staff. This figure is likely to grow to nearly 12 million in the next 18 years. He said that the concept of ethical duties was formally introduced in the USA in 1847 in ‘fairly absolute terms’, with the American Medical Association declaring ‘when pestilence prevails it is the physician’s duty to face the danger, even at the jeopardy of his or her own life’. By the 1980s, with the advent of HIV/AIDS, vigorous debate about the duty to care gave rise to more sophisticated and subtle approaches. These resulted in moral, professional, contractual,
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Dr Andreas Reis Organization.
of
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voluntary and legal obligations, none of them mutually exclusive or interdependent. Prof. Anton van Niekerk, Director of Stellenbosch University’s Centre for Applied Ethics and Chairperson of its Department of Philo sophy, said that the real question was the level and intensity of risk that HCWs were prepared to face. He defined a ‘risk decision’ as being based on a balance between beneficial and adverse outcomes, adding that it was ‘an irony of the modern world that just when we thought we had serious disease more or less under control, AIDS pops out, followed by SARS and now Ebola; who knows what’s around the next corner? For example, what are the possible implications of climate change in terms of disease and the availability of nourishment?’ HCWs had been running personal risks since the time of the Good Samaritan – the prototype of the ‘good doctor’, who even paid the innkeeper to care for the injured man. However,
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professionalism (also among police, soldiers, fire-fighters and lifesavers) implied specialised skills that certain emergency situations called for. A high premium was placed on HCWs’ duty to their patients, particularly when those patients were completely dependent on medical professionals (he cited surgeons and anaesthetists). He drew a distinction between actual and prima facie duties, the former being what one ‘should’ do (a moral decision/action) and the latter a conditional duty that one fulfilled, unless it conflicted with an equal or stronger obligation. Van Niekerk argued that there was no ‘absolute duty of care’. However, a catastrophic humanitarian crisis was a typical example of a prima facie duty that could only be determined once all the relevant factors had been considered.
In Taiwan, China, about 57% of nurses indicated that they were willing to care for patients infected with avian flu, the perception of the importance of their role being the most influential factor. However, in Germany this figure rose to 72%.
South Africa void of ‘duty to care’ directives
Van Niekerk said he could find ‘little or nothing’ in terms of South African directives about the duty to care in high-risk situations. The Constitution, while stating that nobody may be refused emergency medical treatment (Article 27, which the South African Medical Association endorsed), dealt mainly with basic rights such as health, food, water and social security. The Health Professions
Council of South Africa guidelines for good practice urged HCWs to ‘act quickly to protect patients from risk’ if they believed they were impaired, while providing healthcare within the scope of the HCW’s practice, experience and competencies in emergency situations. If unable to do this, they were advised to refer the patient to a colleague or facility where the required care could be provided. Van Niekerk wryly commented that ‘this becomes a bit moot in West Africa’s Ebola areas’. Health catastrophes that imposed the risk of infection, serious illness and the possible death of HCWs could ‘clearly’ not be regarded as requiring an absolute obligation on their part. Services in such situations ‘can and must only be voluntary’. Factors that played a role in deciding the need and efficacy of care in such situations included where the HCWs worked, what their specialty was, whether patients would actually benefit, and whether it was worth while risking HCW lives for people who would die in any case. ‘My argument is that the over-riding moral concern is consent and never coercion,’ he added. Van Niekerk stressed that the time to decide one’s level of commitment in the face of threats to personal safety was not during a public health emergency, but beforehand. Backing Reis’s earlier input, he said that policies became paramount in supporting HCWs to reach a decision themselves. This involved careful evaluation of suitable candidates (did they have dependents, their general psychological disposition, levels of adherence to rules and regulations, i.e. no ‘cowboys’), optimal knowledge of the crisis and ‘risk-required’ behaviour, optimal resources, remunerative support (i.e. danger pay), and realistic expectations from patients.
The tragic vaccination lesson of Haiti
Prof. Dave Durrheim, Director of Public Health Medicine at the University of Newcastle in New South Wales, Australia, said that the first time ethical issues were made as important as any others was after the ‘colossal wake-up call’ of the January 2010 Haiti earthquake, which was immediately followed by a highly destructive hurricane. The double blow cost 220 000 lives with 300 000 injuries. He said that humanitarian workers brought cholera with them and the national government dithered on making a decision about oral vaccination, miring itself in political rationalisation. By the end of last year 700 000 cholera cases had been confirmed, with 10 000 deaths. ‘How many lives could have been saved we’ll never know, but it illustrates the point that a much more generic response is required,’ he said. Asked about the WHO’s tardy response to Ebola in West Africa (i.e. only when international containment became an issue), Reis reluctantly agreed, adding that many infectious diseases were confined to poorer countries ‘with a lack of market to develop drugs and vaccines for these neglected diseases’. ‘It’s very important to create new mechanisms and markets to develop these, not only for Ebola but other tropical diseases. That will prove key,’ he said. The World Bank was trying to implement a policy of universal health coverage ‘with ongoing planning and programmes to raise the general level of health and surveillance systems to enable better preparedness’, he added. Chris Bateman chrisb@hmpg.co.za S Afr Med J 2015;105(6):431-432. DOI:10.7196/SAMJ.9749
Judge nudges dormant euthanasia draft law A terminally ill Cape Town advocate who died of natu ral causes hours before a Gauteng High Court judge granted him the locally unprecedented right to end his life (or have a doctor help him end it) may have speeded up long-recommended progres sive law more in line with provisions of the Constitution. Judge H J Fabricius of the Pretoria Divi sion of the Gauteng High Court this April supported the ‘development’ of common law that predates the Bill of Rights and outlaws euthanasia. He said that serious consideration of new legislation based on
the 1998 recommendations of the South African Law Commission was needed to bring the existing law more in line with constitutional provisions. The 1998 commission found in favour of euthanasia, as long as safeguards were in place to ensure that only terminally ill people in a sound state of mind could request and receive it. However, for 16 years Parliament has failed to act upon or even debate its recommendations. Judge Fabricius’s ruling – and the revival of the complex and hotly contested euthanasia debate – could be the catalyst that leading academics in bioethics and philosophy have been waiting for to enable a more pragmatic
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and human rights-based approach to severe, prolonged and unnecessary human suffering. The judge stressed that his ruling applied only to retired advocate Robin Stransham-Ford, who was 65, and did not change any existing laws prohibiting euthanasia, which would need to be challenged on the individual merits of each case. Assisted suicide or active voluntary euthanasia remains unlawful.
Suffering patient ‘totally rational’, wanted to die on his terms
He said Stransham-Ford, who was suffering from terminal stage 4 cancer with only weeks to live, was highly qualified, ‘of vast
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experience’ in the legal profession and knew exactly what he required and why. The applicant was psychologically assessed and found to have no cognitive impairments; ‘in fact he impressed as being totally rational’. He had a good understanding and appreciation of the nature, cause and prognosis of his illness, plus the clinical, ethical and legal aspects of assisted suicide. Stransham-Ford suffered from severe pain, nausea, vomiting, stomach cramps, constipation, disorientation, weight loss, loss of appetite, high blood pressure and increased weakness and frailty related to his kidney metastases. He was unable to get out of bed and had injections and drips. Unable to sleep without morphine or other painkillers, which made him drowsy, he endured anxiety related to dying while suffering, although he was not afraid of death itself. Lawyers for Stransham-Ford argued that, from a philosophical point of view, there was no difference between assisted suicide by providing the sufferer with a lethal agent or switching off a life-supporting device – or the injecting of a strong dose of morphine with the intent to relieve pain and knowing that the respiratory system would close down, leading to death. Stransham-Ford said in his affidavit that there was no logical distinction between withdrawing treatment to allow ‘the natural process of death’ and physician-assisted death, labelling this distinction ‘intellectually dishonest’. Judge Fabricius said that while there was ‘much to be said’ for this view, he would ‘leave it for the philosophers’ and confine himself to the constitutional debate.
Stransham-Ford said in his affidavit that there was no logical distinction between withdrawing treatment to allow ‘the natural process of death’ and physician-assisted death, labelling this distinction ‘intellectually dishonest’.
Sacredness of the quality of life
The right to life was at the centre of South Africa’s constitutional values, establishing a society where the individual value of each community member was ‘recognised and treasured’, and therefore incorporated the right to dignity. Without dignity, human life was substantially diminished. ‘I also agree with the warning that any pious uncoupling of moral concern from
the reality of human and animal suffering has caused tremendous harm to mankind throughout the centuries.’ Judge Fabricius said he agreed with Stransham-Ford’s contention that it was a fundamental human right to die with dignity, which the country’s courts were constitutionally obliged to advance, respect, protect, promote and fulfil. Contrary to what the respondents (the Minister of Justice and Correctional Services, the Minister of Health, the Health Professions Council of South Africa and the National Directorate of Public Prosecutions, plus Doctors for Life, admitted as ‘friends of the court’) had submitted, the sacredness of the quality of life should be accentuated rather than the sacredness of life per se. The norms of the Constitution should inform the public and its values, ‘not sectional, moral or religious convictions’. Judge Fabricius said it was ‘unfortunate and disturbing’ that societies acquiesced in thousands of deaths caused by weapons of mass destruction. They even seemed to tolerate a ‘horrendous’ murder rate, the ‘daily slaughter on our roads’, impure water and insufficient medical facilities. ‘The state says it cannot afford to fulfil all socialeconomic demands, but it assumes the power to tell an educated individual of sound mind who is gravely ill and about to die that he must suffer the indignity of the severe pain, and is not allowed to die in a dignified quiet manner with the assistance of the medical practitioner.’ The judge said an irony was that ‘we are told from childhood to take responsibility for our lives, but when faced with death we are told we may not be responsible for our own passing … one can choose one’s career, decide to get married, live according to a lifestyle of one’s choosing, consent to medical treatment or refuse it, have children and abort children, practise birth control, and die on the battlefield for one’s country. But one cannot decide how to die.’ The choice of Stransham-Ford was consistent with an open and democratic society and its values and norms as expressed in the Bill of Rights. There was ‘of course’ no duty to live, and a person could waive his or her right to life.
Inevitable abuse ‘unlikely’ – Judge
Judge Fabricius emphasised that any future court could determine the necessary safeguards ‘on its own facts’, saying that there was therefore no ‘uncontrolled ripple effect’, as was put to him by the respondents. He also disagreed with the respondents that his
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Terminally ill retired advocate Robin StranshamFord. Photo courtesy of Gallo Images, by Jaco Marais of Die Burger.
facts-based development of the common law would ‘leave a void that will inevitably lead to abuse’. While the Ministry of Justice and Correctional Services attributed the original lack of action on the Law Commission’s report to ‘other priorities such as HIV and the AIDS epidemic’, it did not say why the report was given no subsequent legislative attention. The South African Medical Association (SAMA) Human Rights, Law and Ethics Committee cautioned health practitioners that the HPCSA’s policies remained in force and said that ‘any such activities’ could result in disciplinary sanctions. It highlighted that the order applied ‘only to this index case’. The committee emphasised the value of palliative care for the relief of pain and suffering for patients who were terminally ill and stressed that ‘pain cannot be viewed as persuasive enough reason to resort to the extreme measure to end one’s life’. SAMA did not support the right to die in law, euthanasia or doctorassisted suicide, which was in line with the HPCSA’s Policies and the World Medical Association’s Guidelines and codes on the subject. The respondents have filed appeals against the ruling, paving the way for a potentially even more far-reaching Constitutional Court ruling. Chris Bateman chrisb@hmpg.co.za S Afr Med J 2015;105(6):432-433. DOI:10.7196/SAMJ.9789
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The Fabricius decision on the StranshamFord case – an enlightened step in the right direction Many diseases are associated with incredible pain and suf fering. Others impair func tion and independence to the extent that human dignity is eroded. In many instances the natural history of such conditions often leads to death within a reasonable period of time. In some cases, protracted ill health, pain, suffering and indig nity ensue. Such circumstances have since time immemorial triggered the debate on euthana sia – a debate on what it means to have a good death. Acting compassionately, many South African (SA) doctors have, to some extent, either passively or actively assisted patients in achieving a good death.
Ending a tormented existence
In recent times, evolving expertise in the medical profession and some technological advances in medical science have inadvertently created the need for assisted suicide. We have found ways to artificially prolong existence at the expense of quality of life, independence and dignity. We ‘play God’ each time we intervene to interrupt the natural progression of disease. Although we primarily intend to act beneficently, we do inadvertently cause harm. Many of our medical and surgical interventions, particularly in the field of oncology, have adverse events that cause incredible suffering in the hope of prolonging life. Such suffering often results in patients choosing death over a severely eroded quality of life. Surely the rights of patients who are enduring unbearable suffering, indignity and pain must be respected, even if this includes the expression of their right to die? Compassion, a primal virtue of the profession, demands that we respect the wishes of patients who choose to end a tormented existence of pain, indignity and dependence. Against this background, I am extremely pleased with the Fabricius judgment in respect of the recent Stransham-Ford case. However, it is clear that my opinion is not shared by the South African Medical Association, the Health Professions Council of South Africa or the Ministry of Health – all major opponents of the Fabricius ruling. Arguments against legalising assisted suicide in SA have included cultural and religious objections, professional duties and moral obligations of doctors and the classic ‘slippery slope’.
‘Cultural resistance’ untested
Assisted suicide may be perceived as the ultimate expression of liberal individualism, a phenomenon common to urban, so-called Western societies. Some have argued that culturally, only a segment of the SA population will support assisted suicide. While this may be true, to a large extent this view remains untested. We have no empirical evidence to support this assertion. It is well documented that African philosophy supports the concept of communal good rather than individual good. However, is this a phenomenon of traditional rural communities only, or does it apply to urban communities as well? The Bill of Rights enshrined in the Constitution is firmly rooted in the tradition of liberal individualism, and the rest of our existing health legislation in the form of statutory law strongly supports individual patient choice, from as early as the age of 12 years – individual informed consent, privacy, confidentiality, truth-telling, and ultimately choice on termination of pregnancy. SA women of all cultural and ethnic origins exercise individual choice every time they opt for a termination of pregnancy, often without consent from the father of the child or the extended family. Do we hear arguments about Ubuntu being advanced with respect to these pieces of legislation that are firmly entrenched in SA society? Admittedly many unexplored religious and cultural views exist with respect to assisted suicide. Many questions remain unanswered. Professional duties of doctors require that they promote life and prevent harm. According to the World Medical Association Declaration on Terminal Illness, adopted in 1983 and revised in 2006, the ‘duty of physicians is to heal, where possible, to relieve suffering and to protect the best interests of their patients’. This statement in and of itself does not exclude assisted suicide, which is intended to relieve suffering and to protect the best interests of the patient. The declaration goes on to assert that the patient’s ‘right to autonomy in decisionmaking must be respected with respect to decisions in the terminal phase of life’. This right to autonomy is, however, restricted to refusal of treatment and requesting palliative treatment to relieve suffering that may have the additional
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effect of accelerating the dying process – the doctrine of double effect. The right to assisted suicide, which would otherwise be included in the patient’s right to autonomy in end-oflife decision-making, is excluded. However, legally this could be regarded as exculpatory language – use of language that limits or waives the rights of patients.
Surely the rights of patients who are enduring unbearable suffering, indignity and pain must be respected, even if this includes the expression of their right to die? Compassion, a primal virtue of the profession, demands that we respect the wishes of patients who choose to end a tormented existence of pain, indignity and dependence.
No ‘slippery slope’
The classic ‘slippery slope’ argument has been advanced by others, with opinions on the euthanasia legislation in the Netherlands presented as evidence. While the Dutch legislation around euthanasia has been based on strict criteria limited to terminal illness only since 2002, recent reports indicate that some doctors are bending the rule and extending the criteria to include less severe forms of illness. There are therefore allegations that some Dutch doctors are treading down the proverbial slippery slope. This is to be expected in a minority of members of the profession in any country – members who cross boundaries in various other aspects of professional conduct too – and legislation should be in place to sanction such transgressions via professional bodies and via the courts. We can learn from the Dutch experience and ensure that the necessary safeguards are built into our end-of-life legislation, such that assisted suicide is an option of last resort. Careful and robust construction of legislation around assisted suicide must therefore make provision for extremely strict criteria, as outlined by the South African Law Commission in 1999. The Death with Dignity Act has been in place in Oregon in the USA for the past 17 years, and unlike the controversial Dutch legislation, appears to be more robust. Finally, legislation merely creates options that can only
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be exercised by patient choice. Assisted suicide does not imply that doctors can force this option onto patients. Our National Health Act supports informed consent, which guards against doctors imposing treatment of any sort on patients. The Act also supports refusal of treatment options recommended by a doctor. Likewise, not all doctors have to participate in assisted dying. The option of conscientious objection by doctors must be included in such legislation.
Concluding thoughts
Assisted suicide is an emotive topic that is ethically, legally and culturally
challenging. Views of all relevant stake holders must therefore be explored before general legislation can be intro duced. Resolving these questions requires intense community engagement, a process that can be initiated via empirical research. However, research can be a slow, costly and challenging process. If the question of assisted suicide is deemed a serious enough matter, a referendum could be held to test societal views in SA on this extremely contentious issue. Until such data are obtained, requests should be treated on a case-by-case basis, as has occurred in the Stransham-Ford matter.
In societies that are allowed to exercise choice in virtually all domains of their lives, limiting autonomy at the end of life is at best myopic and represents the last remnants of paternalism in healthcare. Keymanthri Moodley Director, Centre for Medical Ethics and Law, Stellenbosch University, Tygerberg, Cape Town, South Africa km@sun.ac.za
S Afr Med J 2015;105(6):434-435. DOI:10.7196/SAMJ.9790
Robotic computer system develops high-skill ‘technosurgeons’ Just 15 months after four highly sophisti cated robotassisted da Vinci Surgical Systems were introduced to South Africa (SA), nine local urologists are now ‘flying’ the ZAR23 mil lion devices ‘solo’, while another ten are being mentored on the revolutionary robot ic-assisted laparoscopic tool. The surgical robotic system (four surgeon-controlled operating ‘arms’) was introduced via Earth Medical to four private hospitals in Cape Town, Johannesburg and Pretoria and gives highly skilled, appropriately trained specialists greater vision, precision and control during procedures, going beyond the flexibility and rotational capabilities of the human hand. It has also highlighted innate hospital/doctor and funder tensions in providing expensive but effective hightech medical equipment while maintaining viable patient funding. However, and perhaps most importantly, the da Vinci system has exposed an ‘elephant in the room’ – the internationally aberrant overuse by SA specialists of brachytherapy as a treatment modality for prostate cancer (73% above the global norm). Funded as a prescribed minimum benefit by medical aids (as is open prostatic surgery and traditional keyhole surgery), brachytherapy (the relatively quick and highly strategic placement of a radioactive ‘pellet’ at the prostate cancer site) allows urologists to conduct twice as many procedures a day as is possible with open or laparoscopic surgery.
Top academic compares treatments – and backs the device
Top academic and urologist Prof. André van der Merwe of Stellenbosch University conducted an in-depth comparative literature study of the available treatment modalities for prostatic cancer in SA. He concluded that brachytherapy ‘should be reduced to international proportions (i.e. to 7% from the SA usage figure of 80%)’, with robotic laparoscopic surgery a ‘valuable tool’ in helping achieve this. In his paper, he neutrally comments that ‘should the caring physician benefit from one of the many options, then he might be biased in the manner he counsels the newly diagnosed patient’, adding that a powerful differential exists between the urologist and the patient in consultations after a diagnosis of prostate cancer is made. Izindaba interviews with well-placed expert sources gleaned anecdotal evidence that some urologists often fail to discuss the pros and cons of various therapeutic options with their patients (most have very similar eventual outcomes), pushing brachytherapy and often not mentioning the sometimes appropriate strategy of ‘watchful waiting’ and active surveillance. Dr Jonathan Broomberg, CEO of SA’s largest open medical aid, Discovery Health, said it was ‘critical’ that doctors discuss all available treatment options and the associated risks and benefits with their patients. Patient choice and decisions based on best evidence were ‘vital if we are to achieve better value in our healthcare system’. Van der Merwe described robotic surgery in SA as ‘a major step forward in patient care’ and ‘the beginning of a new chapter in local healthcare’. He concluded that even though it is unfair to compare the early learning curve
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Prof. André van der Merwe.
of robotic prostatectomy with the established learning curve of open and laparoscopic radical prostatectomy, ‘one could confidently say that the oncological (and urinary/sexual) outcomes are similar or better (using the da Vinci system), but definitely not worse’. Most importantly, properly performed, the camera-assisted robotic procedure is the international gold standard in minimally invasive surgery, halving recovery times and enabling unprecedented vision, precision and control (the 3-D HD camera image is magnified 10 times).
As good as its operator
The da Vinci, while an amazing piece of technology, is still a doctor-driven device. Training is taken very seriously, with doctors taught via a console-driven simulator where a 90% pass rate on 35 different test areas is required for hands-on proficiency. They are then sent to Belgium for live porcine practice. Following
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that, a highly experienced international urolo gist is flown out to SA to mentor the local urologists on patients via a ‘buddy system’. This involves two local urologists conducting a daily prostatectomy each for 10 days under supervision, the one local urologist observing and the other operating, and then swapping around in morning and afternoon sessions. This is obviously not teaching the urologist how to do a prostatectomy, but how to apply the da Vinci technology best to benefit from its advantages. The mentor may take over the console from time to time, just as a flying instructor would if potential safety concerns arise. Only when he is satisfied that they can use it safely and proficiently does he sign them off and they can go solo. Mentors insist that all procedures are filmed via the internal camera and e-mailed to them for ongoing monitoring and feedback, and they are continually available for advice and guidance. The average training time to full proficiency can vary from surgeon to surgeon. Simulator and initial local training takes some 45 hours and the overseas ‘wet lab’ training about 16 hours, while the local mentored stint typically covers 12 - 15 cases. Depending on the surgeon’s skill levels and how quickly he or she gets the cases done, they may be spread out over between 3 months and a year, depending on a number of logistical factors. Newly signed-off urologists are counselled about the critical importance of patient selection, with obese patients initially avoided at all costs.
Wider application imminent
If the hospital and its doctors follow the proper surgery protocols, operations are safe, reproducible and result in reduced compli cations, minimal blood loss and improved
functional and oncological outcome. According to Earth Medical, the rigorous training pathway eliminates any ‘short cuts’. Future applications for da Vinci surgery in SA would include appropriate colorectal and gynaecological proce dures, and with over a year of successful use in prostatectomies, the intention is to move to other urological procedures including partial nephrectomies and and cystectomies. One local hospital manager who has overseen the da Vinci introductory phase is Hein Calitz, general manager of Durbanville’s Medi clinic Hospital. Quizzed on the health economics, Calitz said an entire operation cost about ZAR190 000 (including doctor and allied professionals’ fees), of which they could recover only about ZAR125 000 - 135 000 from some of the medical aids. However, certain medical aid schemes would only pay for open surgery and brachytherapy, flatly refusing to fund robotic surgery. ‘At present we’re writing that da Vinci medical aid payment shortfall off. We’re not recovering from the patient yet. We’re still crunching the numbers. It’s for now more important to do volumes to get the surgeons fully trained than worry about getting a better price than ZAR125K and/or the balance in patient co-payments.’ He intimated that over time, doctors would try and convince patients that it was worth their while to pay in the ZAR65 000 shortfall, although this could be phased in with patients paying half of this amount for the next year. Calitz said that the robot system was as susceptible to advancing technology as any other computer device, so that within 5 - 6 years it would probably need replacing. His hospital group had built ZAR40 000 into the overall procedure price to recover some of the equipment expense. Calitz said when Mediclinic motivated for higher medical aid
payouts for its robotic prostatectomies, the medical aids’ response was that this would require an unrealistic increase in membership, or premium hikes, to make it financially viable. He said that punting procedure volumes, potentially improved surgical outcomes and vastly reduced patient recovery times cut no ice with medical aids, challenged as they already were by soaring new technology costs. Broomberg told Izindaba that Discovery Health had performed a detailed health economic analysis on the use of the da Vinci robotic system for prostatectomy. Based on this, they funded the da Vinci robotic prostatectomy up to a ‘defined rand limit’, which was currently at a 40 - 60% premium over the cost of the open prostatectomy procedure. ‘Our analysis indicates that this premium is the maximum that can be justified in terms of the incremental benefit of the da Vinci system, and also represents a sufficient reimbursement to the hospitals for the cost of the device. We’ve agreed a full reimbursement arrangement with some hospitals, but unfortunately, other hospitals insist on charging patients a higher rate, resulting in co-payments for some patients.’ Koert Pretorius, CEO of Mediclinic, said his company viewed the da Vinci system as research and development and a way of exposing doctors to the best research and technology while giving patients access to the latest treatment modalities. ‘In principle we’re prepared to make a contribution in the introductory phase, it’s not just about money for us,’ he said. Chris Bateman chrisb@hmpg.co.za S Afr Med J 2015;105(3):435-436. DOI:10.7196/SAMJ.9464
Case study: COPIC COPIC is a doctors’ insurer based in Colorado, USA. They operate an in-house reporting system called the ‘Three Rs’ programme (Recognise, Respond, Resolve), where any doctor who has experienced an adverse outcome or had their patient express dissatisfaction with their care can contact a specific COPIC administrator to arrange their intervention. According to the COPIC website, the goals of the programme are ‘to maintain the physician-patient relationship, facilitate open and honest communication and disclosure, and reimburse the patient for related out-of-pocket medical expenses’.[1] A series of interviews with patients who had participated in the programme revealed, tellingly, that: ‘When the communication with the physician was good, open, and honest, the outcome was viewed as an honest mistake. Patients referred to their outcomes under these circumstances as both forgivable and understandable. Conversely, when the communication was perceived as poor or non-existent, the same outcome was viewed as an error or negligence.’[2] Of the 1 829 patients who had received reimbursement of their medical expenses through the programme, only 3.4% went on to make a claim against their doctor. While not officially described as a complaints system, COPIC’s programme is an example of dissatisfaction handled effectively with a demonstrable effect on the likelihood of litigation. 1. www.callcopic.com/copic-services/safety-and-risk/Pages/3rs.aspx (accessed 7 October 2014). 2. Lembitz A. Litigation alternative: COPIC’s 3Rs program. AAOS Now 2010;4(9). www.aaos.org/news/aaosnow/sep10/managing7.asp (accessed 5 May 2015).
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References: 1. Davies, N. Advice Document: Fixed dose combination for adults accessing antiretroviral therapy (Southern African HIV Clinicians Society). S Afr J HIV Med. 2013;14(1 Suppl):41-43. 2. Meintjes G, Maartens G, Boulle A, et al on behalf of the Southern African HIV Clinicians Society. Guidelines for antiretroviral therapy in adults. S Afr J HIV Med. 2012;13(3):114-133. S4 ATROIZA (Film-coated tablets). Reg. No.: 45/20.2.8/0172. Each film-coated tablet contains tenofovir disoproxil fumarate 300 mg, efavirenz 600 mg and emtricitabine 200 mg. Lactose monohydrate 120 mg. S4 EFLATEN (Film-coated tablets). Reg. No.: 45/20.2.8/0171. Each film-coated tablet contains tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg and efavirenz 600 mg. Lactose monohydrate 60 mg. Mylan (Pty) Ltd. Reg. No.: 1949/035112/07. Building 6, Greenstone Hill Office Park, Emerald Boulevard, Modderfontein, 1645. Tel: (011) 451 1300. Fax: (011) 451 1400. For full prescribing information refer to the package insert approved by the medicines regulatory authority. M0632 May-15.
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RECOMMENDATIONS
Management of pulmonary hypertension M R Essop, N Galie, D B Badesch, U Lalloo, A G Mahomed, D P Naidoo, M Ntsekhe, P G Williams Prof. Mohammed R Essop is head of the Division of Cardiology at Chris Hani Baragwanath Hospital and the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa, and co-chairman of the Working Group Committee on Pulmonary Arterial Hypertension; Prof. Nazzereno Galie is Associate Professor of Cardiology and Head of the Pulmonary Hypertension Centre, University of Bologna, Italy; Prof. David B Badesch is Professor of Medicine in the Division of Pulmonary Sciences, Critical Care Medicine and Cardiology, and Clinical Director, Pulmonary Hypertension Center, University of Colorado, Denver, Colorado, USA; Prof. Umesh Lalloo is a pulmonologist in private practice at Mount Edgecombe Hospital, Durban, SA; Prof. Achter Goolam Mahomed is Head of the Intensive Care Unit, George Mukhari Academic Hospital, Sefako Makgatho Health Sciences University, Pretoria, SA; Prof. Datshana P Naidoo is head of the Division of Cardiology, Inkosi Albert Luthuli Hospital and School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban; Prof. Mpiko Ntsekhe is head of the Division of Cardiology at Groote Schuur Hospital and the Faculty of Health Sciences, University of Cape Town, SA; and Dr Paul G Williams is a pulmonologist at Milpark Hospital, Johannesburg and co-chairman of the Working Group Committee on Pulmonary Arterial Hypertension. The authors constitute the Working Group Writing Committee of the South African Heart Association/South African Thoracic Society. Corresponding author: M R Essop (mohammed.essop@wits.ac.za)
Pulmonary arterial hypertension (PAH) is a potentially lethal disease mainly affecting young females. Although the precise mechanism of PAH is unknown, the past decade has seen the advent of many new classes of drugs with improvement in the overall prognosis of the disease. Unfortunately the therapeutic options for PAH in South Africa are severely limited. The Working Group on PAH is a joint effort by the South African Heart Association and the South African Thoracic Society tasked with improving the recognition and management of patients with PAH. This article provides a brief summary of the disease and the recommendations of the first meeting of the Working Group. S Afr Med J 2015;105(6):437-439. DOI:10.7196/SAMJ.9307
Lack of awareness of pulmonary arterial hypertension (PAH) on the part of both patients and caregivers, and failure of public and private funders to provide resources for the management of the disease, have meant that patients have little or no access to any of the treatments approved by international guidelines. Recognising the plight of patients with PAH, interested individuals were invited to participate in the First Joint South African Heart Association (SA Heart)/South African Thoracic Society (SATS) Working Group Meeting, held at O R Tambo Airport, Johannesburg, South Africa (SA), on 23 May 2014. The meeting received official recognition from both SA Heart and SATS. The members of the Working Group Writing Committee of SA Heart/SATS wrote this article and are listed above as authors.
1. F ormat of the joint Working Group Meeting
The meeting was co-chaired by Prof. M R Essop (cardiologist) and Dr P Williams (pulmonologist). Two international experts representing Europe and North America participated in the lectures and discussions. Prof. N Galie from Bologna University, Italy, is chairman of the European Guideline Committee on PAH and guest editor of the Journal of the American College of Cardiology supplement on the Proceedings of the 5th World Society of Pulmonary Hypertension. Prof. D Badesch from the Division of Pulmonary Sciences, Critical Care Medicine and Cardiology, University of Colorado, USA, is an author of the American Guidelines on PAH. Both have published extensively and have been senior investigators in pivotal trials on PAH. In addition, representatives of patient interest groups and medical funders were invited to give their perspective.
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The Joint SA Heart/SATS Working Group Committee concluded that local medical expertise should remain current and not lag behind other developing nations. While PAH remains an uncommon disease, it affects mainly younger people and has a prognosis worse than those of most malignancies, and therefore merits treatment. Although treatment is expensive, it is probably in proportion to that of other diseases with a poor prognosis. The prognosis of PAH is steadily improving as a result of advances in medical therapy, and SA patients should have access to these. In this regard, there is an urgent need for introduction and registration of at least one drug from each of the four major therapeutic classes. Consequently, the Committee unanimously resolved to: (i) increase awareness of PAH, promoting education and research and establishing databases and registries; (ii) provisionally adopt the European Guidelines for PAH[1] as a working document for SA while making amendments pertinent to the practice of medicine in this country; (iii) engage with funders to provide essential therapies to patients with PAH; (iv) inform the Medicines Control Council of the need to expedite approval of essential therapies and encourage suppliers of such therapies to provide these at an optimal cost given SA’s financial constraints; and (v) serve as arbitrator when there are conflicting views on how a patient with PAH should be managed best.
2. Pulmonary arterial hypertension
PAH is a disorder of the pulmonary arterioles characterised by endothelial proliferation, fibrointimal hyperplasia and in situ thrombosis with progressive obstructive vasculopathy, pulmonary hypertension and eventually right ventricular failure and death. Despite significant progress, there are large gaps in the understanding
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of the pathogenic mechanisms and determinants of progression of PAH. The grim prognosis highlights the need for earlier recognition, intensive management, and further clinical and laboratory research. The recently published classification of PAH, repres enting consensus of the 5th World Symposium held in Nice, France, in 2013, recognises five groups of pulmonary hypertension.[2] The term PAH is reserved specifically for group 1 (Table 1).
2.1 Aetiology of PAH
About 20% of patients with idiopathic PAH and 80% of those with heritable PAH have a mutation of the bone morphogenetic protein
receptor (BMPR2) gene, a member of the super-family of TGF proteins. Although the exact mechanism by which BMPR2 mutations result in the PAH phenotype is unclear, inhibition of apoptosis with clonal proliferation of endothelial cells is thought to play a role. Autoimmune diseases most frequently associated with PAH include scleroderma and lupus erythematosus. Not infrequently, idiopathic PAH may be associated with low positive titres of autoantibodies, making it difficult to distinguish it from PAH secondary to autoimmune disease. Consultation with a rheumatologist in these cases is essential.
Table 1. The Nice classification of pulmonary hypertension[5]
PAH occurs in 0.5% of patients with HIV and is associated with a poor prognosis.
2.2 Epidemiology of PAH
Ascertaining the true incidence of PAH is difficult, as the onset is insidious and the diagnosis challenging. Furthermore, symptoms and signs of right ventricular dysfunction and reduction in cardiac output occur when the disease is already advanced. The estimated prevalence of PAH in the developed world ranges from 5 to 15 per million adults.[3] There is no reason to believe that the prevalence in SA is any different. With the huge burden of HIV, a cause of PAH indistinguishable from the idiopathic type, it is likely that there is a large undiagnosed population with this disease.[4]
2.3 Diagnosis of PAH
1. Pulmonary arterial hypertension 1.1 Idiopathic PAH 1.2 Heritable PAH 1.3 Drug- and toxin-induced PAH 1.4 PAH associated with: 1.4.1 Autoimmune disease 1.4.2 HIV 1.4.3 Portal hypertension 1.4.4 Congenital heart disease 1.4.5 Schistomiasis 1’ Pulmonary veno-occlusive disease, pulmonary capillary haemangiomatosis 1’’ Persistent pulmonary hypertension of the newborn 2. Pulmonary hypertension due to left heart disease 2.1 Left ventricular systolic dysfunction 2.2 Left ventricular diastolic dysfunction 2.3 Valvular disease 2.4 C ongenital/acquired left heart inflow/outflow obstruction and familial cardiomyopathies 3. Pulmonary hypertension due to lung diseases or hypoxia 3.1 Chronic obstructive pulmonary disease 3.2 Interstitial lung disease 3.3 Other pulmonary diseases with mixed restrictive and obstructive pattern 3.4 Sleep-disordered breathing
A diagnostic algorithm is shown in Fig. 1. Symptoms of PAH include dyspnoea, fatigue, chest pain, syncope and ankle swelling. Clinical signs lack sensitivity, but in advanced disease include tachycardia, left parasternal heave, loud pulmonary component of the second heart sound, murmurs of tricuspid or pulmonary regurgitation, and evidence of systemic venous congestion. Electrocardiography characteristically shows right axis deviation and right ventricular hypertrophy. The proximal pulmonary arteries are dilated on the chest radiograph, with attenuation of distal vessels together with evidence of right atrial and ventricular enlargement. Echocardiography remains the most useful investigation, allowing measurement of pulmonary artery systolic pressure, exclusion of left heart disease and congenital shunts, and assessment of right ventricular function. Cardiac catheterisation is the gold standard for diagnosis of PAH and in addition allows assessment of disease severity, exclusion of category 2 pulmonary hypertension caused by left heart disease, and testing of pulmonary vasoreactivity.
2.4 Treatment of PAH
3.5 Alveolar hypoventilation disorders 3.6 Chronic exposure to high altitude 3.7 Developmental lung diseases 4. Chronic thromboembolic pulmonary hypertension 5. Pulmonary hypertension with unclear multifactorial mechanisms 5.1 H aematological disorders: chronic haemolytic anaemia, myeloproliferative disease, splenectomy 5.2 Systemic disorders: sarcoidosis, pulmonary histiocytosis, lymphangioleiomyomatosis 5.3 Metabolic disorders: glycogen storage disease, Gaucher’s disease, thyroid disorders 5.4 O thers: tumour obstruction, fibrosing mediastinitis, chronic renal failure, segmental pulmonary hypertension
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PAH patients with vasoreactivity are treated with high-dose calcium channel blockers such as nifedipine. Four classes of drugs are available for non-reactive patients, including the prostacyclin agonists, endothelin receptor blockers, PDE5 inhibitors, and most recently agents that increase availability of cyclic guanosine monophosphate. Combinations of these various classes of drugs seem to be the way forward, but the optimal permutation is still the subject of ongoing research. Other treatments include diuretics, digitalis and
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40%. Nevertheless, survival is 58% at 5 years, indicating a need for more effective diseasemodifying therapies.
Clinical exam, ECG, CXR, echocardiography
Normal
PH confirmed
Look for alternative diagnosis
ABG, ANF, LFTs, HIV, PFT, TOE, V/Q, CTPA, spiral CT, sleep studies
Non-category 1 PH Treat for underlying disease
Uncertain
Cardiac catheterisation and proceed accordingly
Category 1 PAH suspected Cardiac catheterisation
Category 1 PAH confirmed
Vasoreactivity
Calcium channel blockers
No vasoreactivity
PAH-specific therapy
Fig. 1. Diagnostic algorithm for patients with suspected pulmonary hypertension. (ECG = electrocardiography; CXR = chest radiograph; PH = pulmonary hypertension; ABG = arterial blood gas; ANF = antinuclear factor; LFTs = liver function tests; PFT = pulmonary function tests; TOE = transoesophageal echocardiography; V/Q = ventilation-perfusion scan; CTPA = CT pulmonary angiogram; CT = computed tomography.)
ambulatory oxygen with sequential lung transplantation for class 4 patients resistant to all pharmacological agents.
Acknowledgements. The First Joint SA Heart/SATS Working Group on Pulmonary Hypertension Meeting was jointly sponsored by Pfizer, Bayer, Actelion and Equity Pharmaceuticals. None had any say in the format, content or resolutions of the meeting. Attendees at the meeting. Prof. M R Essop, Prof. G Richards, Dr PG Williams, Prof. P Willcox, Dr G Symons, Dr G Calligaro, Prof. U Lalloo, Prof. A Goolam-Mahomed, Prof. P Oluboyo, Prof. D Badesch, Dr M Greenblatt, Dr G Schleicher, Dr B Schar, Dr S Maasdorp, Dr I Hunt, Dr C Smith, Prof. A Cilliers, Prof. A Sarkin, Dr L Steingo, Dr K Govendragaloo, Prof. M Ntsekhe, Dr M Mpe, Dr R Girdwood, Prof. D P Naidoo, Prof. N Galie, Dr H Rens, Mrs J Williams, Mrs C Hill, Mrs N Pillay, Mr D Niemandt.
1. Galie N, Hoeper M, Humbert M, et al. Guidelines on diagnosis and treatment of pulmonary hypertension: The Task Force on Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology and of the European Respiratory Society. Eur Heart J 2009;30(20):2493-537. [http://dx.doi. org/10.1093/eurheartj/ehp297] 2. Proceedings of the 5th World Symposium on Pulmonary Hypertension. J Am Coll Cardiol 2013;62(25_S): D51-116. [http://dx.doi.org/10.1016/j.jacc.2013.10.029] 3. Rich JD, Rich S. Clinical diagnosis of pulmonary hypertension. Circulation 2014;130(20):1820-1830. [http://dx.doi.org/10.1161/ CIRCULATIONAHA.114.006971] 4. Essop MR. Contemporary insights into the pathogenesis, diagnosis and therapy of pulmonary arterial hypertension. Cardiovasc J Afr 2010; 21(6): 334-337.
2.5 Prognosis of PAH
Modern targeted pharmacological therapy for PAH has reduced mortality by about
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Accepted 21 December 2014.
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HEALTHCARE DELIVERY
Rural district hospitals – essential cogs in the district health system – and primary healthcare re-engineering K W D P le Roux, I Couper Karl le Roux is based at Zithulele Hospital, Eastern Cape, South Africa. He is an honorary lecturer in the Primary Health Care Directorate, Faculty of Health Sciences, University of Cape Town, and a member of the Rural Doctors Association of South Africa Executive Committee. Ian Couper, a family physician by training, is Professor of Rural Health at the University of the Witwatersrand, Johannesburg, South Africa. He is Director of the Wits Centre for Rural Health, which was launched in 2009 with a focus on human resources for rural health, and holds a joint appointment in the North West Provincial Department of Health as Head: Clinical Unit (Rural Medicine). His areas of interest are health service development, undergraduate and postgraduate education, research and advocacy. Corresponding author: K le Roux (karlleroux@gmail.com)
The re-engineering of primary healthcare (PHC) is regarded as an essential precursor to the implementation of National Health Insurance in South Africa, but improvements in the provision of PHC services have been patchy. The authors contend that the role of wellfunctioning rural district hospitals as a hub from which PHC services can be most efficiently managed has been underestimated, and that the management of district hospitals and PHC clinics need to be co-located at the level of the rural district hospital, to allow for proper integration of care and effective healthcare provision. S Afr Med J 2015;105(6):440-441. DOI:10.7196/SAMJ.9284
The South African National Department of Health (NDoH) has in the past few years committed to re-engineer and improve primary healthcare (PHC) as an essential precursor to the planned implementation of National Health Insurance (NHI). The Minister of Health, Dr Aaron Motsoaledi, has repeatedly emphasised that the foundation of NHI will be proper PHC, with a focus on prevention and health promotion.[1,2] Unfortunately, improvements in PHC have been slow in coming and the gains made have been patchy at best.[3] There continues to be a gap between policy and implementation, especially in rural districts, that needs to be addressed. We contend that an important reason why the re-engineering of PHC has made so little impact is that the role of the well-functioning district hospital as an essential part of the delivery of PHC services has been ignored. Furthermore, the physical separation of the management of district hospitals and that of PHC clinics in health districts has caused fragmentation and poor integration of care between clinics and hospitals, and has perpetuated a curative instead of preventive mindset at district hospitals – contrary to the PHC approach. Unless district hospitals are strengthened and enabled to function as an essential part of the district health system (DHS), and are seen to be part of the implementation of the PHC approach, the laudable aim of re-engineering PHC in South Africa (SA) is likely to fail. This will be further facilitated if management of (sub-)district health services and district hospitals are co-located.
Background – weakness of PHC delivery in SA and plans to improve this
Over the past 20 years, the SA PHC system has undergone a process of significant realignment and change. The philosophy of PHC has been set down as the foundation principle on which the public health system is to be built, in line with the ideals of the 1979 AlmaAta Conference and clear evidence of the effectiveness of the PHC approach.[4]
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The DHS is the vehicle that the NDoH has used in its attempt to provide comprehensive PHC to all SA citizens. This has required significant restructuring of systems, including the redrawing of district boundaries to fit in with municipal boundaries, provincialisation of healthcare facilities, reorganisation of referral pathways and appointment of district management teams. Hundreds of new clinics have been built, nurses have been trained as PHC practitioners, community health workers have been sent into people’s homes, and the SA immunisation schedule has been expanded to the envy of most developing countries. Yet, by the NDoH’s own admission, ‘insufficient attention has been given to the implementation of the PHC approach that includes taking comprehensive services to communities, emphasising disease prevention, health promotion and community participation’.[5] This is illustrated by poor outcomes in critical areas such as maternal and under-5 mortality rates, despite the relatively high expenditure on health in SA.[6] While acknowledging that the HIV epidemic has had a devastating impact, it is clear that good-quality, comprehensive and integrated PHC has remained an elusive goal, which has led the NDoH to refocus on PHC in the past few years. After a visit to Brazil by several senior members of the NDoH in 2010, discussion documents were compiled outlining the Department’s plan to re-engineer PHC.[5,7] This plan hinges on community-based care through ward-based outreach teams, more effective use of community health workers, leadership, support and planning by district clinical specialist teams (DCSTs), and improving school health services. Unfortunately, despite much initial optimism from civil society and government role players, the implementation of a re-engineered PHC has faced significant challenges and appears to have made little impact (T Padayachee et al., ‘The status of the implementation of primary health care re-engineering’ (Health Systems Trust, 2014) – poster presentation at the Public Health Association of South Africa Conference 2014, accessed via personal communication). The goal of good-quality, comprehensive PHC services remains elusive.
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Two major areas that need to be addressed
There are several reasons why the re-engineering of PHC has been disappointing, including the fact that hardly any extra resources were committed to the initiative, apart from budgeting for the DCSTs. Two of the most important reasons relate to the essential place of the district hospital within the DHS, especially in underserved rural areas. Firstly, as documents outlining the re-engineering process confirm, the critical role that well-functioning district hospitals can play in the delivery of PHC services was unfortunately completely overlooked.[5,7] This apparent oversight may reflect the fact that, historically, the hospicentric approach to care has been a major impediment to the implementation of the PHC approach. However, it is clear from World Health Organization, Health Systems Trust and even NDoH documents that the role of the district hospital as the vehicle for implementing the PHC approach is an extremely important one.[8-11] In our opinion, high-quality, comprehensive PHC services will only be achieved if the district hospitals are central to the planning, integration and delivery of PHC services, and are seen as key implementing vehicles for PHC revitalisation, especially in rural areas. The advantages of well-run district hospitals are significant, as they are able to attract and retain a core community of skilled healthcare workers (unlike community health centres, where the core is too small), act as a hub from which PHC services can be supported and organised, and serve as a vital link in the referral chain. District hospitals are also very cost-effective if measured by cost per disability-adjusted life year gained, both for inpatient care and essential surgical care such as caesarean sections.[9,12] There are several rural hospitals (such as Mseleni and Bethesda in northern KwaZulu-Natal Province and Zithulele in the Eastern Cape) with a core of long-term clinical staff that have made outreach to clinics a priority;[13] as a result, PHC services have been greatly improved in the areas served by these hospitals. Regular outreach has supported clinic nurses, improved quality of clinical care and patient satisfaction, and been essential to down-referral of patents on antiretovital therapy. Secondly, and related to what has been set out above, in most health subdistricts the management and organisation of PHC clinics has been completely separated from that of district hospitals. This has led to fragmentation and a vertical, silo-type approach to the different programmatic aspects of PHC. As a result, district hospitals stand alone and disconnected from PHC services in a district or subdistrict and from the clinics that refer to them. This is partly responsible for the curative mindset that continues to bedevil the approach to healthcare delivery, rather than the community-orientated approach with a focus on illness prevention and health promotion that is so desperately needed. The situation has been described as follows: ‘having separate management structures for your hospital and for clinics would be like a human body having one brain that controlled your legs and another brain that controlled your arms – it could work, but it would never be as good as one brain coordinating all limbs’.[14] The way in which healthcare services in districts have been organised does not make practical sense, and is also, according to the Disease Control Priorities Project, economically wasteful because the failure to recognise the interrelationship between local- and district-level facilities has resulted in inefficiency and high costs in service provision.[9] The need for the establishment of amalgamated primary care management teams (PCMTs) cannot be over-emphasised. Based
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at the district hospital, PCMTs would oversee clinic and district hospital care as an integrated whole, and mitigate the disconnect that currently exists between district and subdistrict management teams and clinicians (nurses, doctors and therapists). If the NDoH seeks to improve PHC, district hospitals need to be strengthened and fully integrated into the DHS. The PHC approach needs to be integral to thinking at all levels in the DHS, with clinical managers, doctors and therapists at district hospitals having a clear understanding that they are responsible for the health of all individuals in their hospital’s catchment area, and not just patients who walk through the hospital gate. This will reduce the centralisation of resources, preventing district hospitals from absorbing too much time and attention, and allow for continuity of care within the context of a team working across the (sub-)district. Feedback and communication between district hospitals and clinics need to be strengthened in both directions, and skills and resources at district hospitals must be mobilised to improve clinic and community care. Clinic outreach, use of standard clinical protocols, planning and training emanating from district hospitals all need to be co-ordinated by PCMTs, with support from the DCSTs, and clinicians should be strongly supported in their mission to provide care for the greater community.
Conclusion
The current modus operandi of separating the management of clinics and district hospitals within the DHS is often dysfunctional (particularly in the rural areas) and undermines effective provision of PHC in a (sub-)district. ‘Re-engineering of PHC’ will continue to be ineffectual unless the critical role of the district hospital in the delivery of good-quality PHC services is recognised. Not only should the district hospital be the site where PCMTs are based, it should also serve as a hub of expertise, training, supervision and support for its feeder clinics and be the guardian of the health of each member of community it serves. The well-functioning district hospital, in the context of the integrated DHS, should be the cornerstone of attempts to build a strong and comprehensive PHC system and a healthier SA. 1. Business Day Live. Primary healthcare will be heartbeat of NHI, says health minister. http://www. bdlive.co.za/national/health/2013/10/16/primary-healthcare-will-be-heartbeat-of-nhi-says-healthminister (accessed 13 October 2014). 2. Minister Aaron Motsoaledi: Health Department Budget Vote 2013/14. http://www.gov.za/speeches/ view.php?sid=36484 (accessed 13 October 2104). 3. Business News, IOL. Mountain to climb in primary health care. http://www.iol.co.za/business/news/ mountain-to-climb-in-primary-health-care-1.1584301#.VDw1HOfq3gx (accessed 13 October 2104). 4. Rohde J, Cousens S, Chopra M, et al. 30 years after Alma-Ata: Has primary health care worked in countries? Lancet 2008;372(9642):950-961. [http://dx.doi.org/10.1016/S0140-6736(08)61405-1] 5. Barron P, Shasha W, Schneider H, et al. Re-engineering Primary Health Care in South Africa. Department of Health, Pretoria. Discussion document. 2010. www.anovahealth.co.za/images/uploads/ PHC_rengineering_narrative_24_Nov_Final.dot (accessed 4 May 2015). 6. Chopra M, Daviaud E, Pattinson R, Fonn S, Lawn JE. Saving the lives of South Africa’s mothers, babies, and children: Can the health system deliver? Lancet 2009;374(9692):835-846. [http://dx.doi. org/10.1016/S0140-6736(09)61123-5] 7. Pillay Y, Barron P. The implementation of PHC re-engineering in South Africa. Public Health Association of South Africa, 2011. http://www.phasa.org.za/the-implementation-of-phc-reengineering-in-south-africa/ (accessed 20 October 2104). 8. Department of Health, Pretoria. A district hospital service package for South Africa – a set of norms and standards. 2002. www.kznhealth.gov.za/norms.pdf (accessed 4 May 2015). 9. English M, Lanata CF, Ngugi I, Smith PC. The district hospital. In: Jamison DT, Breman JG, Measham AR, et al., eds. Disease Control Priorities in Developing Countries. 2nd ed. Washington, DC: World Bank, 2006. http://www.ncbi.nlm.nih.gov/books/NBK11749/ (accessed 13 October 2014). 10. McCoy D. The role of the district office in the DHS. Health Systems Trust, 1998. http://www.hst.org.za/ publications/role-district-office-dhs (accessed 20 October 2014). 11. Van Lerberghe W, Lafort Y. The role of the hospital in the district: Delivering or supporting primary health care? World Health Organization, 1990. http://apps.who.int//iris/handle/10665/59744 (accessed 20 October 2014). 12. McCord C, Chowdhury Q. A cost effective small hospital in Bangladesh: What it can mean for emergency obstetric care. Int J Gynecol Obstet 2003;81(1):83-92. [http://dx.doi.org/10.1016/S00207292(03)00072-9] 13. RuDASA, RHAP. The district hospital and PHC. http://www.rhap.org.za/the-district-hospital-andphc/ (accessed 20 October 2014). 14. McCoy D. District hospitals. Health Systems Trust, 1998. http://www.hst.org.za/publications/districthospitals (accessed 20 October 2014).
Accepted 12 December 2015.
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CLINICAL ALERT
Encephalopathy after persistent vomiting: Three cases of non-alcohol-related Wernicke’s encephalopathy K Antel, N Singh, B Chisholm, J M Heckmann Katherine Antel, MB ChB, and Nevadna Singh, MB ChB, are both based in the Department of Medicine, Faculty of Health Sciences, University of Cape Town, South Africa. Briony Chisholm is an Information Pharmacist at the Medicines Information Centre in the Division of Pharmacology in the same department, and Jeannine M Heckmann is an Associate Professor in the Division of Neurology, Department of Medicine, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town. Corresponding author: J M Heckmann (jeanine.heckmann@uct.ac.za)
Wernicke’s encephalopathy (WE) is a medical emergency. Although WE is commonly viewed in the context of alcoholism, it can be caused by thiamine deficiency secondary to persistent vomiting. Non-alcohol-related WE may be more catastrophic in onset and less likely to present with the classic features than WE with alcoholism as a cause. We describe three cases of WE due to persistent vomiting without alcoholism in patients with hyperemesis gravidarum, drug-induced hyperlactataemia, and an acute gastrointestinal illness in an already malnourished individual. Our cases highlight the importance of recognising WE when undernutrition, which may be caused by gastrointestinal disease or surgery, or malignancy, is compounded by vomiting. Expert guidelines suggest that WE must be considered in the emergency room in any individual with disturbed consciousness of unknown cause. Treatment is with parenteral thiamine before glucose administration. S Afr Med J 2015;105(6):442-443. DOI:10.7196/SAMJ.9299
Wernicke’s encephalopathy (WE) is an acute neurological condition caused by thiamine deficiency. Classically, patients with WE are thought to present with eye signs, ataxia and confusion. However, only 20% in fact have this triad of symptoms. In addition, non-alcohol-related WE is more likely to present acutely and with atypical features than WE with alcoholism as a cause.[1] In the absence of a point-of-care diagnostic test, WE needs to be considered and pre-emptively treated in individuals at risk to avoid catastrophic consequences.[1,2] We describe three cases encountered over 3 years at Groote Schuur Hospital, Cape Town, South Africa, to highlight the importance of treating any individual with disturbed consciousness of unknown cause with parenteral thiamine before glucose is given.[1,3]
Case reports Case 1
A 16-year-old scholar presented to a community hospital with a 2-day history of confusion and paraparesis. She had been vomiting daily owing to a concealed 17-week pregnancy. There was no history of alcohol or drug use. The admitting doctors noted that she had confusion, nystagmus, ataxic arms and paraparesis. She was given intravenous fluids containing glucose and transferred to our institution within 3 days for brain magnetic resonance imaging (MRI). We found her to be agitated and confused. She was tachypnoeic and tachycardic, but her blood pressure and the findings on cardiac and chest examination were normal. She had gaze-evoked nystagmus, past-pointing in the arms, and areflexic, flaccid, paralysed legs. She was unable to sit owing to truncal ataxia. The results of laboratory investigations were normal, including renal and thyroid function, electrolytes and vitamin B12 levels; transaminase enzymes were only mildly elevated. The cerebrospinal fluid (CSF) was normal. A chest radiograph showed borderline cardiomegaly, an electrocardiogram demonstrated diffuse T-wave inversion inferolaterally, and an echocardiogram was normal.
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Nerve conduction studies were consistent with a sensorimotor axonopathy. Brain computed tomography (CT) showed symmetrical hypodensities in the caudate nuclei and magnetic resonance imaging (MRI) showed an increased signal on T2-weighted/fluid attenuation inversion recovery (FLAIR) sequences in the same region, although extending to involve the anterior lentiform nuclei (Fig. 1). A clinical diagnosis of WE with beriberi was made after ~6 days of symptoms. Intravenous (IV) thiamine was started (300 mg 8-hourly for 14 days) and continued (as 100 mg daily orally) thereafter. After a few days the patient started to speak, albeit confabulating, and the nystagmus resolved. She had a spontaneous abortion 4 weeks later. She developed severe neuropathic pain in the lower limbs that was partially responsive to carbamazepine and amitriptyline. She was discharged to inpatient rehabilitation therapy after 3 months, remaining wheelchair bound with severe Korsakoff ’s amnesia, confabulation and poor attention.
Case 2
A 48-year-old HIV-positive woman who had been on antiretroviral therapy (ART) for a year was admitted to a secondary-level hospital with nausea, abdominal pain and persistent vomiting for 1 month. She had an abnormal baseline creatinine level of 117 μmol/l, reportedly as a result of previous kidney stones. Her ART regimen consisted of lamivudine, stavudine and efavirenz. The CD4 count was 220 cells/µL and the viral load was suppressed. She was on no other medication and did not use alcohol. On admission she was found to have lactic acidosis (lactate 8.0 mmol/L; pH 7.2) as a complication of stavudine and was dis charged on Aluvia (lopinavir/ritonavir) and efavirenz. A month later she was readmitted with ongoing abdominal pain and vomiting. She was dehydrated (creatinine 158 μmol/L) with hyperlactataemia (lactate 8.9 mmol/L; normal pH) and was treated with IV fluids containing glucose. After 3 days she complained of dizziness and double vision. A CT scan of the brain was normal. The CSF was found to have a high protein level (1.45 g/L; normal <0.4 g/L) but was acellular and serologically negative for syphilis. The efavirenz was stopped and she was transferred to our institution.
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A
B
Fig. 1. (A) Case 1. CT brain scan soon after the patient presented to the secondary-level hospital, demonstrating symmetrical hypodensities in the caudate nuclei (white arrow). (B) Brain FLAIR MRI scan showing increased signal intensities in the caudate heads (large black arrow) and asymmetrical (left > right) anterior lentiform nuclei (predominantly putaminal nuclei) bilaterally (small black arrow).
On admission she had tachycardia, tachy pnoea and a normal blood pressure. She was confused with gaze-evoked nystagmus and bilateral abducens nerve palsies, was areflexic with mildly reduced power and limb dysdiadochokinesia, and could not sit because of severe truncal ataxia. Apart from a lactate level of 5.7 mmol/L, laboratory test findings, including vitamin B12 measurement, were normal. A clinical diagnosis of WE secondary to hyperlactaemic-induced vomiting was made. She was treated with IV thiamine (100 mg 8-hourly for 14 days) followed by 100 mg orally daily. Within 24 hours the nystagmus resolved and by 14 days her eye movements were normal and the ataxia had improved to the extent that she was able to mobilise with support. At discharge she could walk independently, albeit with a broad-based gait.
Case 3
A 22-year-old man with no background illnesses had been admitted to a regional hospital intensive care unit with a rapidly deteriorating respiratory condition requiring intubation and mechanical ventilation. He was noted to have ptosis and difficulty in swallowing, and was treated with IV immunoglobulin and prednisone. Very little recovery occurred over the next 2 months and he was transferred to our institution with a tracheostomy and a percutaneous endoscopic gastrostomy (PEG) in situ, although he had been successfully weaned off ventilatory support. We found him to be alert but emaciated. He had severe spastic anarthria without any volitional movement of the bulbar musculature, but was able to communicate in writing. It
was discovered that he had been a substance abuser (daily marijuana and Mandrax) for several months, but had not used alcohol. He had remained well despite neglecting his diet until he developed a gastrointestinal illness characterised by severe vomiting and diarrhoea the week before admission. He then developed relatively acute difficulties with his gait and breathing, as well as bulbar symptoms. Examination showed the following striking findings: non-fatigable ophthalmoplegia and bilateral ptosis, and severe pseudobulbar palsy with a profoundly brisk jaw (and head) jerk. He was unable to open his mouth or move his tongue. The limbs were areflexic but with normal power. Findings on sensory examination were normal. His gait was mildly ataxic, but he reported that it had improved. The results of laboratory investigations were normal, including thyroid and liver function tests and CSF examination. HIV and syphilis serology were negative. A brain MRI scan was normal. Based on the presentation comprising spastic pseudobulbar palsy, ophthalmoplegia and ataxia following a period of profuse vomiting on a background of malnutrition, the patient was treated for WE with IV thiamine (100 mg 8-hourly for 7 days) and then 100 mg daily orally. He responded within days with resolution of the eye signs and recovery of bulbar function. The PEG was removed within a month. He made a full recovery, stopped all substance use and is living a productive life.
Discussion
We describe cases of WE due to persistent vomiting but without alcoholism: hyperemesis gravidarum, drug-induced hyperlactataemia,
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and an acute gastrointestinal illness in a malnourished individual. Our cases highlight the importance of recognising WE when undernutrition is compounded by vomiting.[1] WE requires IV thiamine, and treatment delay can result in significant morbidity.[1] Thiamine is a cofactor for key enzymes involved in brain energy production such as the Krebs cycle. Brain structures such as the periaqueductal nuclei, mamillary bodies and thalami with high metabolic requirements are especially vulnerable to thiamine deficiency.[2] In non-alcoholic WE, the cerebellar vermis, midbrain reticular formation and caudate nuclei are frequently involved.[1] Although neuroimaging often reflects signal changes in these structures, an MRI scan may be normal.[1] The clinical diagnosis of WE can be con firmed by measuring thiamine levels using high-performance liquid chromatography.[1] However, the diagnosis is dependent on clinical awareness and increases dramatically (to 85%) in the presence of two of the following features: dietary deficiencies, any eye signs, cerebellar signs, and either mild memory impairment or altered mental status.[1] There is poor consensus on the optimal IV thiamine dose, although all agree that oral treatment is ineffective. Guidelines conclude that administering thiamine intramuscularly (as the package insert suggests) is painful and that IV thiamine is safe. They recommend IV infusions of 200 - 500 mg thiamine diluted in 100 ml normal saline or 5% glucose, given over 30 minutes three times a day for 3 days, followed by 200 mg three times daily until the patient has improved substantially before reverting to 100 mg daily orally.[1,4] Importantly, all high-risk individuals presenting to the emergency room should receive 200 mg parenteral thiamine before any administration of glucose.[1] Acknowledgements. We thank our colleagues in the Division of Neurology at Groote Schuur Hospital who assisted with the care of these patients: Christine Albertyn, Kathleen Bateman, Alan Bryer, Eddy LeePan, Alan Stanley and Lawrence Tucker. 1. Galvin R, Brathen G, Ivashynka A, Hillbom M, Tanasescu R, Leone MA, EFNS. EFNS guidelines for diagnosis, therapy and prevention of Wernicke encephalopathy. Eur J Neurol 2010;17(12):1408-1418. [http://dx.doi.org/10.1016/j.annemergmed.2007.02.007] 2. Donnino MW, Vega J, Miller J, Walsh M. Myths and misconceptions of Wernicke’s encephalopathy: What every emergency physician should know. Ann Emerg Med 2007;50(6):715-721. [http://dx.doi. org/10.1111/j.1468-1331.2010.03153.x] 3. Ganie NS, Janse van Rensburg E. Wernicke’s encephalopathy as a complication of gastroparesis after emergency partial antrectomy. S Afr Med J 2015;105(2):157. [http://dx.doi.org/10.7196/SAMJ.9271] 4. Sechi G, Serra A. Wernicke’s encephalopathy: New clinical settings and recent advances in diagnosis and management. Lancet Neurol 2007;6(5):442-455. [http://dx.doi.org/10.1016/ S1474-4422(07)70104-7]
Accepted 18 December 2015.
FORUM
CLINICAL PRACTICE
A bedside system for clinical grading of parotid gland enlargement M Tshifularo Prof. Mashudu Tshifularo, MB ChB, MMed (ORL) (Cum Laude), FCS (SA) ORL, is Head of Otorhinolaryngololgy at the School of Medicine, Faculty of Health Sciences, University of Pretoria, South Africa, and the Steve Biko Academic Hospital Complex, Pretoria. He has an interest in innovative medical practice and surgical techniques, endoscopic technology, development of medical devices, and medical education and training. Corresponding author: M Tshifularo (mashudu.tshifularo@up.ac.za, tshifularom@surgeon.co.za)
There are limited data on grading of parotid gland mass, and currently no bedside clinical grading system is available. Parotid enlargement is common in patients with HIV/AIDS, and the size of the gland can change depending on the progression of disease, with or without treatment. This needs to be recorded accurately and communicated properly. A novel system for bedside clinical grading of parotid gland enlargement using a soft tape measure is proposed. S Afr Med J 2015;105(6):444-445. DOI:10.7196/SAMJ.9404
There are limited data on the grading of parotid gland mass, and currently no bedside clinical grading system for benign parotid gland enlargement exists. The TNM (tumour-node-metastasis) clinical staging system is used for malignant tumours of the salivary glands (including the parotid), but not for benign lesions. Parotid gland enlargement is common among patients with HIV/AIDS. The size of the gland can change depending on disease progression with or without treatment (antiretroviral therapy). A scientific, reliable and cost-effective way to measure parotid gland enlargement is necessary. Such a clinical grading system would be helpful in communicating the degree of parotid gland enlargement to patients and colleagues.
calculated as a normative value (Fig. 3). A bedside clinical grading system is proposed,
based on the size increase from the normative value (Table 1) (illustrated in Fig. 4). B
A
Fig 1. (A) Total surface area diameters of the normal adult parotid gland (oblique line A - C (lateral bone of eye socket to mastoid tip) + vertical line B - D (root of helix to angle of mandible), in centimetres). (B) In an enlarged parotid gland, new points C1 and D1, extensions along A - C and B - D to the most distal palpable edges along the same lines (A - C + B - D, in centimetres) give an estimation of the total palpable surface area diameters of the enlarged gland to offer a clinical grading system. A
B
The proposed grading system
The bedside clinical grading of parotid gland enlargement proposed is based on a study of 100 subjects (37 males, 63 females). None had diseases of the parotid gland. A soft measuring tape was used to measure the estimated surface diameters of the parotid gland in two dimensions, i.e. vertically and obliquely within its anatomical surface area (Figs 1 and 2, B - D, D1 and A - C, C1). All measurements were done by the author. The two measurements were added together and the total estimated size of the surface of the normal parotid gland was
Fig. 2. Demonstration of bedside measurement of the parotid gland with a tape measure. Left: oblique line A - C; right: vertical line B - D.
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N=100 Healthy adult subjects
Helix to mandible (B - D): Females 9.58 cm Males 9.9 cm
Table 1. Proposed grading system for benign parotid gland enlargement Clinical grade
Size increment above normative value 21 cm
Total
Grade I
2 cm
21 - 23 cm
Grade II
4 cm
23 - 25 cm
Grade III
6 cm
25 - 27 cm
Grade IV
8 cm
27 - 29 cm
Grade V
>9 cm
>30 cm
Eye to mastoid (A - C): Females 10.55 cm Males 11.45 cm
This grading system has revolutionised recording and communi足 cation of parotid gland enlargement in the ENT, head and neck and HIV/AIDS clinics at Steve Biko Academic Hospital, Pretoria, South Africa.
B - D (9.575 cm) + A - C (10.98 cm) = 20.575 cm Fig. 3. Total estimated surface area diameters of the normal adult parotid gland (summation of the two measurements of vertical line B - D and oblique line A - C, in centimetres). The normative value in this study for both males and females is 20.575 cm (21 cm) surface area diameters.
Conclusion
Fig. 4. The right parotid gland is grade III (26 cm) and the left is grade V (33 cm).
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A bedside clinical system for grading of ben足 ign parotid gland enlargement is proposed. It is a scientific, easy, simple, repeatable and reliable way of communicating parotid gland size using a soft measuring tape. Accepted 23 January 2015.
FORUM
PERSONAL VIEW
Reflections of a retiree: 40 years in public service at Chris Hani Baragwanath Academic Hospital K R L Huddle Prof. Ken Huddle was chief specialist and head of the Department of Medicine at Chris Hani Baragwanath Academic Hospital and the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa, until his recent retirement. Corresponding author: K R L Huddle (kenneth.huddle@wits.ac.za)
These reflections on a 40-year career at Chris Hani Baragwanath Academic Hospital, Soweto, Johannesburg, South Africa (SA), provide an insight into the rollercoaster experience of service in the public healthcare sector in SA. S Afr Med J 2015;105(6):446-450. DOI:10.7196/SAMJ.9354
‘Dear Leo, ‘It is with sincere and deep regret that I write to you. Following the events of the past several months at Baragwanath, our department’s morale has hit rock bottom. We gain some strength from the fact that we are fighting for a just cause, but are deeply saddened by the turn of events with victimisation and intimidation being the order of the day. Your gloomy predictions of a deteriorating situation are now indeed taking place. I am quite sure that this deplorable situation must sadden you immensely, having seen a department grow and develop under your guidance, only to crumble in the face of authoritarianism. Someday, somewhere, someone may appreciate our concern for the welfare of our patients, and not term it a crime. ‘After much soul-searching I have decided to withdraw my application for the Chair of Medicine at Baragwanath, as I am unable to see any future prospects for improvement at this hospital. My enthusiasm has disappeared, only to be replaced by disappointment and sadness. I apologise if I have let you down.’
An inauspicious beginning
I wrote this letter to the immediate past-Chairman of the Department of Medicine at Chris Hani Baragwanath Academic Hospital (CHBAH), Prof. Leo Schamroth, on 27 January 1988. My abject despondency was as a result of the vicious and punitive response of the Transvaal Provincial Administration to our letter in the SAMJ in 1987, signed by 101 doctors, deploring the appalling conditions our patients had to endure in the medical wards of Baragwanath Hospital. I proceeded to make enquiries regarding the setting up of practice at one of the private clinics in Johannesburg. A meeting with the Chief Executive Officer of this clinic proved decisive in my career pathway. I naively thought that I would like to provide a service to patients, especially those suffering from endocrine/diabetes disorders. This did not particularly impress the CEO, whose next question totally floored me: How much money did I think I would generate for the hospital? The rest of the interview in his wood-panelled office flashed past in a blur. I could not get out of his office soon enough. After reflection and a rethink, I reconsidered my position and decided to reapply for the Chair of Medicine at Baragwanath. Although the interview at the University of the Witwatersrand (Wits) went relatively well (I was told), the provincial administration still had their knives out for me. They refused my appointment on the basis of ‘my lack of administrative experience’. I was instructed to take on
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the Department of Medicine as Acting Head for a year, during which I was to enrol in administrative courses at the Wits Business School. I complied and reapplied for the post. I recall that on this occasion the university was represented by very senior academic staff and also included Helen Suzman. I took up the post on 1 May 1990. Sadly, Prof. Schamroth died after a long illness on 24 May 1988 at the age of 63. Thus began my long and challenging association with South Africa (SA)’s largest hospital. I started my professional life as an intern at Baragwanath in 1975 and proceeded through the ranks, culminating in 25 years as Chair and Head of Department. I characterise my career at CHBAH as that of a rollercoaster; many ups and downs with substantially more ups than downs: exhilarating, frustrating, satisfying, rewarding. Some of my thoughts and observations follow.
On mentorship
I was very privileged in my career to have the guidance and wisdom of wonderful mentors: Prof. Leo Schamroth, world-renowned electro cardiologist, gifted teacher and orator; Prof. Asher Dubb, doyen of clinical teaching in SA and renowned medical philatelist; and Prof. David Blumsohn, the oracle and moral compass of our hospital, and an expert in ancient languages. They provided me with ongoing support, encouragement and advice, which I valued greatly. Each in his own way was a role model for me, and of course, for other students and staff. I was also fortunate to work with excellent academic heads of our department: Profs Tom Bothwell, John Milne, Patrick MacPhail, Joe Veriava and Sarala Naicker. It is apparent to me that in our teaching hospitals in SA we have insufficient role models to inspire, guide and advise junior doctors. This deficit needs to be addressed as a matter of urgency if we are to ensure that our up-and-coming doctors conduct themselves as true professionals and are a credit to the noble profession of medicine.
On life as a physician in a public sector teaching hospital
I am often asked, ‘Are you still at Bara?’ My standard reply is, ‘Yes, of course, where else should I be?’ I have felt very privileged and proud to have been given the opportunity to work at this famous hospital and to head the Department of Medicine for 25 years. I have worked with many wonderful people and experienced the wonderful camaraderie among our staff. I have learned so much from the patients we have
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served – the incredibly wide spectrum of pathology, the enduring of illness with dignity and stoicism, the fact that our patients still trust and respect their doctors and are grateful for whatever we are able to do for them. I have enjoyed teaching and mentoring students immensely – they keep me young and invigorated. Making people better and having a positive influence on the career of young professionals are two of my greatest areas of satisfaction. I have enjoyed the excitement of clinical research, especially audit research leading to better clinical practice. All these experiences, collectively, have enriched my life immensely. I feel very strongly that heads of departments should be full-time appointments without the option of private practice. The job, if done properly, is all-consuming and one needs to devote all one’s time and energy to the task. Of course, there are downsides to the job. Administration is a very necessary part of the head’s job, which would be made much easier in the public sector if hospital administration was more efficient and effective. This area has been a battle for me. During the apartheid era our hospital was a neglected black hospital with all the negative consequences; after 1994, the situation, from an administrative point of view, has sadly not shown the positive change we all so hopefully envisaged.
On the AIDS pandemic
The AIDS pandemic has swept across the globe since the 1980s, leaving a path of devastation and misery, especially for those sufferers from the developing world who have had no or little access to treatment. SA has been the epicentre of this pandemic. We diagnosed our first case of HIV/AIDS at CHBAH in 1987. During the 1990s we began admitting more and more patients with AIDS and its complications, to the extent that this disease accounted for the majority of our medical admissions. We were swamped and overwhelmed. There was little understanding for our plight by hospital administrators – I made numerous representations to our administration pleading for more staff and resources to cope with this crisis. There was little appreciation for the complexity of this disease and its complications, for the fact that it required expensive investigations and treatment, for the fact that it was Internal Medicine that faced the brunt of the epidemic, and for the fact that the disease was associated with a very high mortality in young people, which proved very demoralising for our young doctors. The period of AIDS denialism during the time of President Thabo Mbeki and his Minister of Health, Manto Tshabalala-Msimang, denied patients the effective antiretroviral treatment that had become available. This was immoral and indefensible, and cost the affected population dearly. The response of our department was to take care of the AIDS sufferers as best we could. We initiated the development of a Division of Infectious Diseases under Prof. Alan Karstaedt to do research on HIV/AIDS and to facilitate therapy. The advent of antiretroviral therapy over the past decade provided our patients and us with some hope. It has changed a uniformly fatal disease into a chronic, manageable disease. Our Infectious Diseases Unit has played a major role in the fight against HIV/AIDS. As an aside, our doctors in the Department of Medicine were never distracted in rendering care to these patients despite the ever-present risk to themselves through needlestick injuries – one study performed at two of our academic hospitals found that 70% of interns reported one or more needlestick injuries during their internship year. We take this risk very seriously and developed a 24-hour assistance programme for our staff to provide counselling and immediate prophylactic treatment where indicated. The emotional trauma associated with a needlestick injury is considerable. The other side of the coin is that we have learned an enormous amount from this epidemic – a new chapter of medicine has been added to our knowledge base. The scientific discoveries regarding
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HIV/AIDS have been very illuminating; the social and ethical aspects have been equally challenging and humbling. Although HIV/AIDS (and its partner, tuberculosis (TB)) have dominated the medical landscape for over two decades, we have not lost sight of the fact that non-communicable diseases, such as diabetes, hypertension, ischaemic heart disease, and cancer, are reaching epidemic proportions in the developing world, including the population of Soweto whom we serve. When I started out as an intern at Baragwanath it was a rarity to find a case of acute myocardial infarction in the wards – in fact, a special ward round was arranged to discuss this rare condition. We now have a coronary care unit dedicated to managing the significant numbers of patients suffering from ischaemic heart disease. There is no doubt that non-communicable diseases deserve the same degree of attention and activism as the communicable ones. There is appreciation for this by the Ministry of Health – Dr Aaron Motsoaledi has made a huge positive impact on stemming the tide of HIV/AIDS, and he is starting to impact on the non-communicable diseases. In my view he has been an outstanding Minister of Health, the best in living memory, and deserves our full support in his quest to provide an equitable healthcare system of good quality for all South Africans. We are a long way from this goal.
On general v. subspecialty medicine
The Department of Medicine at CHBAH is the largest and busiest in SA. We administer over 700 beds with a >90% bed occupancy, an average of 100 patients are admitted per day, and over 157 000 outpatients are seen per year. The medical staffing comprises 30 interns, 20 medical officers, 40 registrars, 15 subspecialty fellows, 27 specialists, 11 principal specialists, and 2 chief specialists. The department is divided into 5 large general medical units and 8 subspecialty divisions (Cardiology, Endocrinology, Gastroenterology, Haematology, Infectious Diseases, Nephrology, Pulmonology and Rheumatology). We are fortunate in having highly qualified and committed specialists on our staff. Despite its size, the department is able to render a quality service to our patients with reasonable efficiency. In my view the functional structure of the department is ideal for the service and teaching needs; the emphasis is on general medicine with subspecialty back-up. The department and its staff fall under one clinical head who holds the post of Chief Specialist and Professor of Medicine. The model has prevented the fragmentation of medicine into ‘organ’ specialities, a trend which has become pervasive locally and internationally. The patients have the benefit of being exposed to generalists and subspecialists (if required) under one roof with a more holistic approach to care. Trainees also benefit substantially from this comprehensive exposure. There is now a move internationally to strengthen general medicine.
On bedside teaching
There has always been an emphasis on bedside teaching in our department. We have been blessed with some of the great clinical teachers who have inspired others to follow suit. Bedside teaching should not be seen as an anachronism; it is the ideal platform for teaching and training. Our patients are the focus of the encounter. A history is elicited from them, a focused examination follows, a final assessment and diagnosis/differential diagnosis is made, and therapy is planned. I have always thought this akin to sleuth work which provides for much of the excitement and satisfaction in clinical medicine. It allows the teachers to perform as role models for their students in the real-life situation. Through one’s interactions with the patients, one is able to influence the future professional conduct of students and young doctors. The art of bedside teaching has virtually been lost in the USA – some of the medical schools have
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recognised this deficit and are attempting to resuscitate this mode of teaching. A recent buzz-word in the USA and UK is ‘patient-centred’ medicine because doctors, as a result of the technological advances in medicine, have moved away from what should be their priority: the care of the patient. We would do well in SA to maintain our focus on bedside teaching, emphasising the centrality of the patient in all our deliberations and interventions. To become a good teacher one needs to be involved in the assessment of students. I participated in examinations throughout our country over many years and this has enriched my own teaching. I have also played a role at various levels in the College of Physicians of SA, a body which plays a valuable role in ensuring that high standards of medicine are maintained.
On the value of quality staff
Over the years I have realised that one of the most important functions of a head of department is to recruit and retain high-quality staff. I recall a statement emanating from a world leaders’ forum which indicated that leading entrepreneurs and captains of industry look for three basic qualities when recruiting new staff: intelligence, energy, and integrity. It was also stated that it was of little value having the first two without the last. I also subscribe to this view but would add a fourth quality for doctors: compassion. Once you have selected the appropriate people with these qualities and the requisite training, qualifications and experience, the rest of the job is relatively easy. We are fortunate that in our department we have a large number of these high-quality people who contribute substantially to maintaining high standards of service, teaching and research. It is also essential to have good staff retention strategies. I have found that it is important to thank staff for their contributions, to reward them for significant effort with promotion or various awards, and to value them as people. This creates a positive spiral. Much of what I have said regarding the recruitment and retention of quality doctors also applies to the nursing staff. I have had the privilege of working with many outstanding nurses during my career; they have reminded me on numerous occasions just how important and integral they are to quality healthcare. However, I feel the standards of nursing have declined in recent times and the ethos of nursing is under threat. Nurses need to be brought back to their primary function, patient care, and freed up from excessive administrative and clerical duties. The nursing curriculum needs to be reviewed and brought in line with patients’ needs. The conditions of service for nurses need to be improved, taking into account that the vast majority of nurses are women with particular needs. For example, part-time posts need to be created for women with young children; crèche facilities should be available on site.
On noteworthy projects
There are many sources of satisfaction for heads of departments: watching the growth and professional development of one’s staff; enthusing students on a bedside teaching round; making difficult diagnoses and making sick people better; reaping the rewards of providing good leadership in good and bad times; and, ultimately, observing the success of one’s department in its three areas of responsibility – teaching, service and research. I am glad to say that I have experienced all of these to a greater or lesser extent. On a more personal level I have derived enormous satisfaction from three projects I have been involved in.
The institution of comprehensive diabetes services at CHBAH
The initiation of palliative care services at CHBAH
I lost my wife, Penny, to breast cancer in 2000. This was a devastating blow to my family which took us many years to come to terms with. Dealing with cancer on a personal level prompted me to reflect on how we were dealing with the care of patients suffering from cancer in my department. We were certainly making the diagnoses and instituting appropriate treatment for those who were potentially curable, but we were offering very little to those individuals not amenable to curative therapy. A shameful statistic that I recall is that an audit of the use of morphine at our hospital at the time revealed close to zero use. In response to these serious shortcomings I sent one of my senior consultants, Dr Allison Russell, on a sabbatical to the UK to study the hospice care for which they are renowned. She returned full of enthusiasm and proceeded to establish a nursedriven palliative care service at our hospital. Patients in need are now appropriately counselled, debilitating symptoms are controlled, and families have become involved in the care of their loved ones. This unit has grown into a fully fledged Palliative Care Centre recognised by the Gauteng Department of Health and the Wits Faculty of Health Sciences. Palliative care now forms part of the undergraduate medical curriculum. Dr Natalya Dinat made significant contributions to this centre on the retirement of Dr Russell. More recently, Dr Charmaine Blanchard has taken over the reins and is extending the influence of palliative care beyond the hospital to the community centres in Soweto. We are grateful to these three individuals and their staff. It is with a deep sense of satisfaction that I reflect on the positive impact that this service has made and continues to make to patients and their families. Sadly, to my knowledge, this palliative care centre is the only one of its kind in the public sector in SA. We need more of the same throughout our country.
The initiation of an outreach programme
As a young physician starting out at CHBAH in the early 1980s I concluded that the diabetes services at this hospital were rudimentary and totally inadequate, only focusing on acute admissions with little
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emphasis on preventive strategies and patient education. These findings were supported by a study undertaken at the time showing high rates of morbidity and mortality, many of which were potentially preventable. With this appalling situation in mind, I set out to completely revamp the diabetes services at this hospital. Perhaps the most pivotal intervention we undertook was the introduction of specialised diabetes nurse educators, which revolutionised the care of our patients. I arranged for these nurses to be trained in all aspects of diabetes management both locally and overseas. They are now worth their weight in gold. Most of them have worked in our service for over 15 years. They are all multilingual, are highly motivated and trained, and are able to effectively relate to our patient population. They educate our patients comprehensively on all aspects of diabetes and its management so as to empower them to take good care of themselves. We have been able to show the benefits of a 30-year sustained intervention on the lives of our diabetic patients through audit research. Our service is comprehensive and provides for both inpatients and outpatients, for the young and the old, as well as for pregnant women. It is the largest service for diabetic patients in the public sector in SA. Clearly, these benefits have accrued through a team effort involving specialists, nurse educators, podiatrists and other healthcare personnel. I am indebted to them and to the patients who have taught us so much. It is with a sense of pride that after 35 years, I hand over the baton, with the knowledge that quality care will continue to be available to our patients for the foreseeable future.
One of the problems bedevilling our public sector regional hospitals is staffing, especially the filling of specialist posts. Just over 5 years ago, we in the Department of Medicine realised that we had insufficient subspecialty training posts for the increasing number
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of newly qualified physicians. We met with the Chief of Operations at the Gauteng Department of Health and came up with a winwin solution: the regional hospitals in our area would give us their unfilled specialist posts to fill in return for a continuous specialist service run by us at these hospitals. I initiated such an outreach programme to Sebokeng Hospital, an 800-bed regional hospital approximately 60 km south of CHBAH with a catchment population of over 1.1 million. Currently, two to three young physicians rotate through the Department of Medicine at Sebokeng Hospital every 3 months. This has ensured a continuous specialist service at this hospital with the following benefits: better administration, better structure and supervision of junior staff, better discipline, an ongoing teaching programme, and ultimately, more effective patient care. This department is now highly rated by interns and is attracting staff. Recently, one of our senior physicians, Dr Arjuna Dissanayake, has taken up the full-time Head of Department post at this hospital. I have no doubt that this appointment came about as a result of the positive spiral created by the outreach programme. We, in turn, have benefited from the expanded pool of subspecialty training posts. There is potential for this type of outreach programme to be extrapolated to other areas of our country.
On the changing demographics of students and staff
When I first started out at CHBAH in 1975 the students and staff were predominantly white and male. Today, we have a far more cosmopolitan mix, much more representative of the SA population. I really appreciate the diversity of our staff which has been an enriching experience for us all – we continually learn from one another and learn to respect and value the views of people from different racial and cultural backgrounds. Our female colleagues have also added great value to our perspectives and have been a very welcome addition to our staff. I feel very strongly that we need to provide a more supportive working environment for female doctors who are starting families. We need more part-time posts with more flexible working hours to allow young women to contribute to their profession at the same time as taking care of their children. These female doctors often feel conflicted; on the one hand they are not doing enough professionally, and, on the other hand, they feel they are neglecting their children. Most of, if not all, the medical classes at our medical schools are now at least 50% female. We should do everything possible to retain these valuable doctors in their profession.
On patient advocacy
Rudolf Virchow (1821 - 1902), the famous German pathologist who is considered ‘the father of modern pathology’, stated that ‘physicians are the natural attorneys of the poor’. I and many of my colleagues subscribe to this viewpoint. During the apartheid era most of our patients from Soweto were poor, socioeconomically deprived, suffering from the ravages of malnutrition, TB and, more recently, HIV/AIDS. Twenty years post democracy, the living conditions of the Sowetan population have improved somewhat, yet the ravages of TB and AIDS persist. This is compounded by the burgeoning epidemic of non-communicable diseases such as hypertension, heart disease, diabetes, respiratory disease and cancer. Throughout my 40-year tenure at Bara I have been struck by the enormous burden of disease experienced by our patients, and humbled by their dignified and courageous response to devastating illness. I have also been struck by the inadequate facilities available to such patients in the public sector, including Bara. Rather than just accepting the status quo, we have fought on behalf of our patients for better facilities and services.
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For example, four of our senior physicians, Drs Blumsohn, Huddle, Krut and Marinopoulos, penned a strong letter to the SAMJ in 1987 protesting the appalling conditions which existed for ward patients at the time. The letter was signed by 101 concerned doctors. This led to the unleashing of a vicious and vindictive response from the hospital authorities. Instead of focusing on the very real and serious problems at Bara, they proceeded to victimise and intimidate the medical staff. A court case ensued in which one of the signatories to the letter, Dr Traub, instituted legal action against the hospital authorities who had refused her further employment. She won her case which was a watershed moment for all those concerned. The Vice-Chancellor, Prof. D J du Plessis, undertook to raise funds from the private sector to provide an extra 320 beds for the Bara patients. The project took a mere year to complete – patients could then be comfortably accommodated. In 2009 I played a role in averting strike action by junior doctors at Bara. This strike was part of a countrywide protest against the slow implementation of the Occupational Specific Dispensation (OSD) – an improved salary structure – for doctors. I felt very strongly that vulnerable patients should never be used as ‘footballs’ in protest action; their trust in the profession should never be betrayed. The senior doctors prevailed – no doctors went on strike at Bara. More recently, I participated as a member of the Concerned Clinicians Coalition at Wits which protested the deficiencies in supply and delivery of drugs, consumables, and equipment to our hospitals in Gauteng. We, together with the Centre for Applied Legal Studies (CALS) at Wits and Section 27, were instrumental in precipitating the signing of an accord between the National Department of Health, the Gauteng Department of Health, and the University of the Witwatersrand in July 2013, in which a turnaround strategy was proposed. Progress thus far has been slow. My colleagues and I also protested the privatisation of public sector beds – Folateng private wards – in several of our public hospitals in southern Gauteng in the face of overwhelming numbers of public sector patients. This is unacceptable and, besides reducing the number of available public sector beds, it leads to a two-tier system of healthcare in the same institution, favouring the private patients. There are many other examples of patient advocacy at our hospital – this has contributed to the ‘soul’ of our institution of which we are very proud. Much remains to be done – a luta continua. One of my pet hates is the use of certain terms which are either demeaning to patients or undermining of the true philosophy of medicine. For example, I frequently overhear junior doctors on the ward using the word ‘turf ’ when referring to the transfer of patients between wards. This is unacceptable and unprofessional. Another example is the use of two expressions which are frequently bandied about: ‘client’ for patient, and ‘healthcare industry’ for the profession. Medicine should not be perceived as a business with a contractual relationship between caregiver and patient, but rather as a noble profession dedicated to serving the needs of people who are ill or in distress, thereby honouring the trust that is so fundamental to our profession.
On the importance of self-audit
Over the years I have encouraged young doctors to follow a career which is characterised by continuous growth and development so as to ensure that they provide the best possible care for their patients. It is, of course, just as important for more senior physicians to follow suit. I have found that for my own personal growth and development, self-audit and reflection has been essential. I recall a talk on how physicians think, which likened an experienced physician’s approach to diagnosis to that of the grand masters
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playing 12 games of chess simultaneously. How do they manage to do this so effectively? By pattern recognition. This is the same for the experienced physician who can often make the diagnosis on a post-intake ward round after only hearing a few of the patientâ&#x20AC;&#x2122;s details. This is different from a â&#x20AC;&#x2DC;spotâ&#x20AC;&#x2122; diagnosis and takes many years of hard work, practice and self-audit to achieve. I personally found that the pieces of the puzzle fell more readily into place 10 years after becoming a physician.
On the importance of family and friends
I am blessed with wonderful family and friends. My wife, Linda, our children, Justine, Natalie and Gregory, our son-in-law, Guy, and our grandchild, Liam, have added immeasurable value and joy to my life. My good friends within and without the profession have
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done likewise. Collectively, they have provided me with a superb supportive framework for my professional and personal life. I am indebted to them.
Conclusion
I am grateful for the opportunity I have had to play a meaningful role in providing healthcare to the community of Soweto and beyond, for the opportunity to teach and mentor students of this noble profession, and for the opportunity to lead a large department of committed and expert specialists in their pursuit of excellence. Ultimately, as doctors, our main focus is on patient care. In this regard, I wish to thank our patients who have taught us so much about medicine and humanity, and who continue to show trust in their caregivers. Accepted 9 January 2015.
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Minimising the ‘cost’ of laparoscopic cholecystectomy Laparoscopic cholecystectomy entered into the surgical treatment of gallbladder disease in 1985.[1] This was at a time when innovation rather than evidence was the driving force for the operation. It became evident that the persistent Achilles heel of this operation was bile duct injury (BDI), the incidence of which has remained twice that of open cholecystectomy. The report by Hofmeyr et al.[2] on the rand cost of surgical repair of BDI for patients treated at the Digestive Diseases Centre at the University of Cape Town Private Academic Hospital is a prudent reminder of the devastating effects of these injuries. This series is the only one to have addressed any aspect of BDI in South Africa (SA), and specifically quantifies the financial cost, an aspect on which there is a paucity of international publications. This study, which analysed the financial implications of the repair of 44 major BDIs, shows that the (average) cost of ZAR220 000 is six times greater than the cost of an uncomplicated laparoscopic cholecystectomy. This does not take into consideration the cost of the initial operation or any radiological or operative interventions that may be required before the patient is transferred for management of the BDI. Inclusion of these costs would raise the amount to at least eight times that of an uncomplicated laparoscopic cholecystectomy. Two international costing studies have addressed this issue. A 2011 US study reported on the cost of 108 BDIs over 18 years.[3] The hospital costs for the 98 major injuries in this series yielded a cost per individual (converted to rands) of ZAR410 000. Twenty-eight patients required interventions before referral with BDI, but these prior costs, as in Hofmeyr et al.’s study, were not factored into the total cost calculation or used as a predictor of increased costs at the institution definitively repairing the injury. A 2008 Swedish study analysed the cost in a much smaller group of 24 patients with 14 minor and only 10 major BDIs.[4] They included in their costing model factors not addressed by the Cape Town group, namely those related to sick leave and loss of productive days. The cost per major injury was ZAR1 080 000. Good national data on the incidence of BDI allowed the Swedish group to calculate the cost per million of the population … ZAR6 000 000. Neither the US nor the Swedish study benchmarked the cost against laparoscopic cholecystectomy, which would have allowed some degree of comparison between studies. Some of the factors that affect the complexity and accuracy of costing models have been alluded to. One of the considerations in the SA context is whether such a detailed private hospital costing model can be applied to BDI repairs performed in state hospitals. The authors’ impressions are that at least 50% of these injuries are managed in state facilities where intensive care and interventional radiology costs, which accounted for 38% of the total cost in Hofmeyr et al.’s[2] study, are difficult to define accurately. The costs of the BDI repair are not the only financial costs. Those arising from the medicolegal ramifications are considerable. In the USA, recently reported data on 248 cases of BDI calculated the average payouts to the plaintiffs who sought legal redress for their injury. The 70% of plaintiffs for whom the court judgment was in their favour received an average compensation of ZAR9 711 600; cases settled out of court received two-thirds of that amount.[5] To these figures can be added the legal fees and the escalating costs of medical protection cover, which in this country have increased tenfold over the past 10 years.[6]
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The non-fiscal ‘costs’ are also highly significant for the patient, the ‘injuring’ surgeon and their families. Several studies have addressed the quality-of-life aspects of patients, both physical and psychological. The former are largely short lived. The latter have been shown in a recent meta-analysis to be remain significant even after long-term follow-up.[7] This is particularly true if revisional bile duct surgery, hepatic resection or liver transplantation are required, all of which also contribute to the risk of death. There is furthermore an adverse impact on the surgeon during the process of litigation, which includes significant stress, anxiety, and loss of productivity resulting from a loss of self-esteem during a legal process hinged on negligence. In SA a less adversarial resolution for both the patient and the surgeon would be in everyone’s interest. Berney[8] outlines the legal framework that would permit a more amicable resolution. Given the grave consequences of a BDI as outlined, active steps need to be taken to reduce the incidence of this complication, and, if it does occur, to optimise management. A multifaceted approach is required. This begins with a registry of all BDIs in SA to quantify the true extent of the problem. As all injuries should be managed by specialist hepatopancreaticobiliary (HPB) surgeons, this should be logistically feasible. Primary prevention would entail a reduction in the number of unnecessary cholecystectomies. Laparoscopic cholecystectomy has doubled the number of cholecystectomies being performed in most countries where it is widely practised,[9] yet the benign natural history of asymptomatic gallstones is unchanged.[10] Secondary prevention would require ensuring that general surgeons are effectively trained in a standard safe method of performing the operation.[11] This must emphasise recognition of the difficult gallbladder and that conversion to a less dangerous laparoscopic approach such as subtotal cholecystectomy or an open procedure is appropriate. There are efforts underway in SA to improve surgical mentorship and the environment to achieve this. Tertiary prevention is essential to help minimise the impact of these complications when they do occur. A BDI should be managed and repaired by an expert HPB team. Repair of a BDI by the injuring surgeon markedly jeopardises the chances of success, especially when delay causes sepsis.[12] In the emergency situation, the priority is to manage systemic and local sepsis effectively and to transfer the BDI patient to a specialised centre as soon as possible. Hofmeyer et al.[2] are to be congratulated on their study aimed at raising awareness of the consequences of BDI. The ‘costs’ are enormous, and the surgical community needs to embrace a multifaceted approach aimed at reducing the impact of this devastating complication. Sandie R Thomson Professor and Head, Division of Gastroenterology, Faculty of Health Sciences, University of Cape Town, South Africa, and Gastrointestinal Unit, Groote Schuur Hospital, Cape Town sandie.thomson@uct.ac.za Martin D Smith Head, Department of Surgery, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa, and Chris Hani Baragwanath Academic Hospital, Johannesburg Corresponding author: S R Thomson (sandie.thomson@uct.ac.za)
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1. Reynolds W, jr. The first laparoscopic cholecystectomy. JSLS 2001;5(1):89-94. 2. Hofmeyr S, Krige JEJ, Bornman PC, Beningfield SJ. A cost analysis of operative repair of major laparoscopic bile duct injuries. S Afr Med J 2015;105(6):454-457. [http://dx.doi.org/10.7196/SAMJ.9038] 3. Cannon RM, Brock G, Buell JF. A novel classification system to address financial impact and referral decisions for bile duct injury in laparoscopic cholecystectomy. HPB Surg 2011;2011:371245. [http:// dx.doi.org/10.1155/2011/371245] 4. Andersson R, Eriksson K, Blind PJ, Tingstedt B. Iatrogenic bile duct injury – a cost analysis. HPB (Oxford) 2008;10(6):416-419. [http://dx.doi.org/10.1080/13651820802140745] 5. Anandalwar SP, Choudhry AJ, Choudhry AJ, et al. Litigation in laparoscopic cholecystectomies. Am Surg 2014;80(6):E179-E181. 6. Bateman C. Medical negligence payouts soar by 132%. S Afr Med J 2011;101(4):216-218. 7. Landman MP, Feurer ID, Moore DE, Zaydfudim V, Pinson CW. The long-term effect of bile duct injuries on health-related quality of life: A meta-analysis. HPB (Oxford) 2013;15(4):252-259. [http:// dx.doi.org/10.1111/j.1477-2574.2012.00586.x]
8. Berney CR. Major common bile duct injury and risk of litigation: A surgeon’s perspective. Am J Surg 2012;204(5):800-802. [http://dx.doi.org/10.1016/j.amjsurg.2011.06.009] 9. Talseth A, Lydersen S, Skjedlestad F, Hveem K, Edna TH. Trends in cholecystectomy rates in a defined population during and after the period of transition from open to laparoscopic surgery. Scand J Gastroenterol 2014;49(1):92-98. [http://dx.doi.org/10.3109/00365521.2013.853828] 10. Sakorafas GH, Milingos D, Peros G. Asymptomatic cholelithiasis: Is cholecystectomy really needed? A critical reappraisal 15 years after the introduction of laparoscopic cholecystectomy. Dig Dis Sci 2007;52(5):1313-1325. [http://dx.doi.org/10.1007/s10620-006-9107-3] 11. Strasberg SM. A teaching program for the ‘culture of safety in cholecystectomy’ and avoidance of bile duct injury. J Am Coll Surg 2013;217(4):751. [http://dx.doi.org/10.1016/j.jamcollsurg.2013.05.001] 12. Flum DR, Cheadle A, Prela C, Dellinger EP, Chan L. Bile duct injury during cholecystectomy and survival in Medicare beneficiaries. JAMA 2003;290(16):2168-2173. [http://dx.doi.org/10.1001/jama.290.16.2168]
S Afr Med J 2015;105(6):451-452. DOI:10.7196/SAMJ.9791
The management of burns begins at home Burn injuries remain a significant cause of trauma, especially in low- to middle-income countries. The start point for reducing burn injuries lies in prevention, and education on risk factors for burn injuries begins in peoples’ homes. The World Health Organization (WHO) [1] in collaboration with various burns societies has prioritised prevention of burns and support for burns control measures. Fire-related burns are responsible for an estimated mortality rate of 6.1/100 000 population per year in Africa,[1] much higher than the 1.0/100 000 in high-income countries. Worldwide, burns account for 10 million disability-adjusted life years. The WHO and burns organisations are aware that in low-income countries, rural and poor urban communities, lacking access to electricity, face a mix of risk factors such as ground-level cooking pots, open wood fires, candles and paraffin (kerosene) stoves of questionable safety.[1,2] Efforts have been made to introduce safer paraffin lamps into South Africa (SA) in the hope that the number of burn injuries will be reduced.[2] Children are at particular risk of household accidents involving cooking pots, open fires and stoves. Research by Scheven et al.[3] and Fiandeiro et al.[4] in KwaZulu-Natal reports that the majority (~70%) of burns occur in children; hot water scalds and burns are responsible for the majority (~60%) of cases. Allorto et al.[5] reported that 83% of burns in children are hot water-related. Of great concern are the number of non-accidental burn injuries (NAIs) in children. Scheven et al.[3] reported 16 cases of NAI in children in KZN (5.4%) and Allorto et al.[5] 12 (5.9%), resulting primarily from immersion of the limbs and buttocks in hot water. The majority (86%) of burn injuries in SA are classified as minor, most being from hot water.[2] First-aid measures are particularly effective. The therapeutic effectiveness of cooling burn wounds is borne out in numerous studies.[6-8] Authors are agreed that the application of cool (not iced) water to burns for 10 - 20 minutes early after the injury improves healing and reduces complications.[6,9-11] However, this simple yet effective treatment was seldom used in the KZN studies. Fiandeiro et al.[4] and Scheven et al.[3] both showed that only about 20% of patients received cool water as first aid, while very few received water cooling for the recommended minimum of 10 - 20 minutes. When large burns are treated, the cautionary mantra of ‘cool the burn and not the patient’ is important – rendering the patient hypothermic from cooling methods does not improve outcome, but rather risks increasing morbidity and mortality.[12] Covering the wound with a dressing also forms part of firstaid measures. Application of extensive dressings and bandages is not recommended because of resultant time delays. Rather, the recommendation is to use a simple dressing such as cling film, which is easily and rapidly applied (thus reducing time delays), provides adequate cover to burn areas, and permits wound inspection without having to be removed when the patient arrives in hospital.[9]
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Pain control is an important early intervention. Cool water applied to the burn site will reduce pain and discomfort, and additional simple analgesia such as paracetamol can be taken at home as soon as possible. With significant burns, stronger, centrally acting analgesics such as opiates may be necessary. The advanced life-support paramedic can initiate an opiate such as morphine during the prehospital phase. Prehospital healthcare practitioners should assess all major burns comprehensively. A primary survey should be carried out, with special attention given to the airway, breathing and circulation. Where required, intubation for airway protection should be considered and intravenous fluids initiated. A final check is required to ensure that related trauma such as fractures and head injury have not been missed and that comorbidities such as epilepsy and electrocution have been considered. The chain of burns treatment begins with prevention, followed by simple first-aid measures and effective prehospital care, consolidated by appropriate assessment and resuscitation in the emergency department and ending with specialist management in a dedicated burns unit with allied rehabilitation facilities. Darryl Wood Division of Emergency Medicine, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa Corresponding author: D Wood (darryl.wood@kznhealth.gov.za) 1. Mock C, Peck M, Peden M, Krug E, eds. A WHO Plan for Burn Prevention and Care. Geneva, World Health Organization, 2008:1-32 2. Rode H, Berg AM, Rogers A. Burn care in South Africa. Ann Burns Fire Disasters 2011;24(1):7-8. 3. Scheven D, Barker P, Govindasamy J. Burns in rural Kwa-Zulu Natal: Epidemiology and the need for community health education. Burns 2012;38(8):1224-1230. [http://dx.doi.org/10.1016/j. burns.2012.04.001] 4. Fiandeiro D, Govindasamy J, Maharaj RC. Prehospital cooling of severe burns: Experience of the Edendale Hospital Emergency Department. S Afr Med J 2015;105(6):457-460. [http://dx.doi. org/10.7196/SAMJ.8705] 5. Allorto N, Oosthuisen GV, Clarke DL, Muckart DJ. The spectrum and outcome of burns at a regional hospital in South Africa. Burns 2009;35(7):1004-1008. [http://dx.doi.org/10.1016/j.burns.2009.01.004] 6. Bartlett, N, Yuan, J, Holland AJA, et al. Optimal duration of cooling for an acute scald contact burn injury in a porcine model. J Burn Care Res 2008;29(5):828-834. [http://dx.doi.org/10.1097/ BCR.0b013e3181855c9a] 7. Demling RH, Mazess PB, Wolberg W. The effect of immediate and delayed cold immersion on burn oedema formation and resorption. J Trauma 1979;19(1):56-60. [http://dx.doi.org/10.1097/00005373197901000-00011] 8. Jandera V, Hudson DA, de Wet PM, Innes PM, Rode H. Cooling the burn wound: Evaluation of different modalities. Burns 2000;26(3):265-270. [http://dx.doi.org/10.1016/S0305-4179(99)00133-3] 9. Allison K. The UK pre-hospital management of burn patients: Current practice and the need for a standard approach. Burns 2002;28(2):135-142. [http://dx.doi.org/10.1016/S0305-4179(01)00083-3] 10. Nguyen NL, Gun RT, Sparnon AL, Ryan P. The importance of immediate cooling – a case series of childhood burns in Vietnam. Burns 2002;28(2):173-176. [http://dx.doi.org/10.1016/S03054179(01)00094-8] 11. Venter THJ, Karpelowsky JS, Rode H. Cooling of the burn wound: The ideal temperature of the coolant. Burns 2007;33(7):917-922. [http://dx.doi.org/10.1016/j.burns.2006.10.408] 12. Singer AJ, Taira BR, Thode HC jr, et al. The association between hypothermia, prehospital cooling, and mortality in burn victims. Acad Emerg Med 2010;17(4):456-459. [http://dx.doi.org/10.1111/j.15532712.2010.00702.x]
S Afr Med J 2015;105(6):452. DOI:10.7196/SAMJ.9627
June 2015, Vol. 105, No. 6
EDITORIAL
Paediatric dental sedation: Will your child return home unharmed? Sedation is widely used to reduce the fear and anxiety associated with dental procedures. In South Africa (SA), this is frequently done in consultation rooms rather than a theatre environment, with the aim of reducing cost and improving patient comfort, particularly in the case of children. Both local and systemic analgesia are combined with sedation. While severe complications are rare, critical incidents such as dysrhythmias or respiratory depression are common. Adverse events occur more frequently and have worse outcomes in the younger age group (<7 years of age).[1] Such events include undersedation (with movement and possible injury), oversedation, oxygen desaturation, airway obstruction, laryngospasm, respiratory and cardiovascular depression or respiratory or cardiac arrest, seizures, unresponsiveness, allergic reactions, vomiting or excessive secretions, with risk of aspiration, and death. Sedation is by nature a continuum from minimally reduced responsive ness to general anaesthesia. Children can easily slip into a deeper level of sedation with respiratory or cardiovascular compromise, depending on individual susceptibility. This tends to happen more readily when more than one drug is used. For this reason, close observation and recorded monitoring, as well as appropriate training in sedation, are essential. Lack of well-kept records is one reason why complications of sedation of children in the dental chair are underestimated. The South African Society of Anaesthesiologists compiled paediatric sedation guidelines in 2010,[2] due for update later in 2015. According to this guideline (and other international guidelines), whenever sedation is attempted in children, personnel must be appropriately trained and include an observer who is not the surgeon. There must be monitoring with appropriate equipment, and resuscitation equipment and resuscitation and antidote drugs must be available. This issue of SAMJ features a well-planned and well-conducted audit of sedation practices in Gauteng Province, SA.[3] The findings are worrying. In only 76% of practices was informed consent obtained before procedures, while only 83% of patients had presedation assessments. Although 41% (95% confidence interval 37 - 51) of dentists provided sedation, only 78% had oxygen available. Almost 20% had no resuscitation equipment available in their practice. Facial masks and airway equipment were present in only 30% of practices. During sedation only 54% of respondents used pulse oximetry, the single means of monitoring that is considered essential for any level of sedation; more than 41% had no monitor available. In 41% of practices the dentist provided the sedation, did the procedure and monitored the childâ&#x20AC;&#x2122;s condition. Two-thirds of practitioners used more than one drug, yet half kept no emergency drugs: flumazenil, an antidote to benzodiazepines, was kept by only 10 15% of practitioners who used benzodiazepines, and only 14% of practitioners using opiates stocked the antidote naloxone. A positive aspect is that in 31% of practices a medical practitioner with training in sedation, and in almost 21% of practices an anaesthetist, was the person primarily responsible for sedation. However, that leaves 48% of children sedated by someone with no training in sedation. The
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majority (90%) of personnel primarily responsible for sedation had Basic Life Support training. The study[3] may be criticised, as numbers were relatively small, and despite good sample size planning a relatively low proportion of the dentists completed the questionnaire. However, although the final number of respondents was only 52, the results probably represent fairly accurately what currently happens in practice. It is also possible that people who did not respond did not want to provide information on practices that they do not feel comfortable with. It is clear that many children in the dental chair may be at risk â&#x20AC;&#x201C; in a situation where complications may not be detected early, and where there is a lack of appropriate knowledge and of drugs or equipment to reverse inappropriately deep sedation and ensure resuscitation. Poor appreciation of the risks and of guidelines, and inadequate training, further aggravate the situation. Fortunately, 82% of respondents stated that they wanted to attend a sedation course. Dental chair sedation is also influenced by cost considerations. According to guidelines, deeper levels of sedation should only take place in a controlled theatre/hospital situation, but medical insurers resist such practice for relatively minor procedures. Medical funders also sometimes refuse to pay for a dedicated sedationist, such as an anaesthetist. If sedation is done in the office, it is the responsibility of the dental practitioner to stock all appropriate drugs and monitoring and resuscitation equipment, all of which is also a cost factor. What should be done? In a developing country such as SA, which is able to provide First-World medicine, the current situation is unacceptable, whether in the best- or the least-funded situation. Acknowledging that even the mildest sedation for an apparently minor procedure may go wrong, the status quo must be improved so that complications, should they arise, will be successfully managed with a good outcome. Awareness of problems that may be associated with dental chair sedation is essential. Training in sedation is vital. Practice should be according to national and international guidelines, with awareness of and ability to determine the level of sedation. No sedation should be attempted without ready availability of essential drugs and monitoring and resuscitation equipment. Ultimately a system of accreditation of training and facilities should be created, supervised and inspected by the regulating authority. B J S Diedericks Department of Anaesthesiology, Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa Corresponding author: B J S Diedericks (diedericksbjs@ufs.ac.za) 1. Cote CJ, Notterman DA, Karl HW, et al. Adverse sedation events in pediatrics: A critical incident analysis of contributing factors. Pediatrics 2000;105(4):805-814. [http://dx.doi.org/10.1542/ peds.105.4.805] 2. South African Society of Anaesthesiologists. Guidelines for the safe use of procedural sedation and analgesia for diagnostic and therapeutic procedures in children. South Afr J Anaesth Analg 2010;16(5 Suppl):S1-S37. 3. Bham F, Perrie H, Scribante J, et al. Paediatric dental chair sedation: An audit of current practice in Gauteng. S Afr Med J 2015;105(6):461-464. [http://dx.doi.org/10.7196/SAMJ.8788]
S Afr Med J 2015;105(6):453. DOI:10.7196/SAMJ.9756
June 2015, Vol. 105, No. 6
RESEARCH
A cost analysis of operative repair of major laparoscopic bile duct injuries S Hofmeyr,1,2 MB ChB, FCS (SA), MMed (Chir), Cert Gastroenterol (SA) Surg; J E J Krige,1,2 MB ChB, MSc, FACS, FRCS, FCS (SA); P C Bornman,1,2 MB ChB, MMed (Surg), FCS (SA), FRCS (Edin), FRCS (Glasg); S J Beningfield,3 MB ChB, FFRad (SA) epartment of Surgery, Faculty of Health Sciences, University of Cape Town, South Africa D Surgical Gastroenterology Unit, Groote Schuur Hospital, and University of Cape Town Private Academic Hospital, Cape Town, South Africa 3 Department of Radiology, Faculty of Health Sciences, University of Cape Town, South Africa 1 2
Corresponding author: S Hofmeyr (stefhofmeyr@sun.ac.za)
Background. Major bile duct injuries occur infrequently after laparoscopic cholecystectomy, but may result in life-threatening complications. Few data exist on the financial implications of duct repair. This study calculated the costs of operative repair in a cohort of patients who underwent reconstruction of the bile duct after major ductal injury. Objective. To calculate the total in-hospital cost of surgical repair of patients referred with major bile duct injuries. Methods. A prospective database was reviewed to identify all patients referred to the University of Cape Town Private Academic Hospital, South Africa, between 2002 and 2013 for assessment and repair of major laparoscopic bile duct injuries. The detailed clinical records and billing information were evaluated to determine all costs from admission to discharge. Total costs for each patient were adjusted for inflation between the year of repair and 2013. Results. Forty-four patients (33 women, 11 men; median age 48 years, range 30 - 78) underwent reconstruction of a major bile duct injury. First-time repairs were performed at a median of 24.5 days (range 1 - 3 662) after initial surgery. Median hospital stay was 15 days (range 6 86). Mean cost of repair was ZAR215 711 (range ZAR68 764 - 980 830). Major contributors to cost were theatre expenses (22%), admission to intensive care (21%), radiology (17%) and specialist fees (12%). Admission to a general ward (10%), consumables (7%), pharmacy (5%), endoscopy (3%) and laboratory costs (3%) made up the balance. Conclusions. The cost of repair of a major laparoscopic bile duct injury is substantial owing to prolonged hospitalisation, complex surgical intervention and intensive imaging requirements. S Afr Med J 2015;105(6):454-457. DOI:10.7196/SAMJ.9038
Although laparoscopic cholecystectomy was introduced more than two decades ago, the incidence of bile duct injuries has not diminished and injury still occurs in 0.4% of operations, twice as often as with open cholecystectomy.[1-4] While minor injuries with duct continuity can be treated successfully with endoscopic stenting without recourse to operation, major injuries with duct division are life-threatening and may require complex biliary reconstructive surgery.[5] Optimal evaluation of a major bile duct injury requires careful, co-ordinated, multidisciplinary assessment by a knowledgeable group of surgeons, intensivists, endoscopists and interventional radiologists.[6,7] Reparative biliary surgery is technically demanding and should be undertaken only by a surgical team with expertise and established credentials. The implications of a major bile duct injury can be profound, with the spectre of protracted hospitalisation and invasive investigations, the anxiety of major reconstructive surgery, a lengthy rehabilitation period, decreased quality of life, loss of income, and in some cases prolonged and unpleasant litigation. The financial burden implicit in injury management and the consequences for the patient are significant, yet no local and few international data are available to assess the cost of definitive bile duct reconstruction accurately.[8-10] In this study we calculated the total in-hospital costs of definitive repair of major laparoscopic bile duct injuries by including all costs incurred from referral to discharge from hospital with a durable repair.
Methods
Study population
Between March 2002 and October 2013, 52 patients were referred to the University of Cape Town Private Academic Hospital (UCTPAH),
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South Africa (SA), for assessment of a suspected or confirmed major injury to the extrahepatic bile duct sustained during a laparoscopic cholecystectomy. Information was obtained from a prospective database on all patients with a laparoscopic bile duct injury that is maintained in the Surgical Gastroenterology Unit, Groote Schuur Hospital, Cape Town, by a dedicated research assistant. Data collected and entered included patient demographics, indication for laparoscopic cholecystectomy, recognition of injury during or subsequent to cholecystectomy, mode of delayed presentation, delay in referral, investigations and procedures performed before referral, type of injury according to the Strasberg classification,[2] investigations and procedures prior to definitive surgery, timing of repair, length of intensive care unit (ICU) and total hospital stay, investigations and procedures after repair, and complications. A cohort of 44 patients who had operative repair of a major bile duct injury was identified and analysed. Eight patients were excluded because they had a minor bile duct injury that did not require surgery (n=2) or complete and detailed billing information was not available on the hospital computer records (n=6). The information captured on the database, as well as the detailed original clinical notes, was reviewed. The study was approved by the University of Cape Town Health Research Ethics Committee (HREC REF 600/2014). Each patient underwent detailed preoperative assessment to define the extent of the bile duct injury, including a multiphase computed tomography (CT) scan, magnetic resonance cholangio pancreatography (MRCP) and percutaneous transhepatic cholangio graphy (PTC) with biliary drain placement. Possible arterial injuries were identified by a contrast-enhanced CT scan and duplex Doppler flow assessment if required.
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RESEARCH
The interval from initial injury to definitive repair was defined as the number of days from initial injury to definitive repair at UCTPAH. This interval was inclusive of previous repairs performed at outside medical centres. For the purpose of the study, ‘first repairs’ were defined as patients without a previous attempt at repair or an attempted repair by any method other than a bilioenteric anastomosis. ‘Revision surgery’ was the term used when a repair was performed on patients with a previous hepatico- or choledochojejunostomy. Biliary injuries were classified using the Strasberg classification of bile duct injuries:[2] type A – bile leak from cystic duct stump or gallbladder bed; type B – aberrant right hepatic duct occlusion; type C – aberrant right hepatic duct transection; type D – partial (<50%) transection of a major bile duct; and type E – >50% transection or complete transection of a major bile duct (further subclassified as E1 – >2 cm from the confluence of the left and right hepatic ducts; E2 – <2 cm from confluence; E3 – no common hepatic duct remnant with an intact hepatic duct confluence; E4 – destruction of the hepatic duct confluence; and E5 – aberrant right sectoral duct in conjunction with an injury to the common hepatic duct).
Operative technique
A standard operative technique was used for all bile duct reconstructions. The full technical details have been published previously.[11] In brief, a bilateral subcostal incision 3 cm below the costal margin was used. An Omnitract fixed body wall retractor provided exposure to the upper abdomen. All adhesions in the right upper quadrant were dissected free and released. The hepatic arterial and portal venous vasculature in the hepatoduodenal ligament was identified and preserved. The site of the bile duct injury was identified. In patients with a complete duct transection, the previously placed percutaneous transhepatic biliary drains were located. All fibrotic tissue in the proximal hepatoduodenal ligament adjacent to the injury was excised. The hepatic ducts identified at the level of the hepatic duct confluence were exposed by incising the hilar plate at the base of the quadrate lobe and lowering the extrahepatic left hepatic duct and the hepatic duct confluence. The ducts were dissected until healthy, well-vascularised ductal mucosa was identified. An anterior longitudinal incision was made in the extrahepatic component of the left hepatic duct using the Hepp-Couinaud approach. Careful choledochoscopy was done to identify the
right and left segmental ducts and ensure the absence of intrahepatic stones. The operative choledochoscopic findings were reconciled with the preoperative MRCP and PTC imaging to ensure identification of all ducts. A 40 cm retrocolic jejunal Rouxen-Y loop was fashioned and a side-to-side hepatojejunal anastomosis constructed using preplaced 5/0 absorbable monofilament sutures. The hepatojejunal anastomoses were stented using the existing percutaneous transhepatic biliary catheters. A side-to-side enteroanastomosis was done in the infracolic compartment. One week postoperatively, percutaneous cholangiography was performed via the biliary drains to confirm an intact biliary-enteric anastomosis. The percutaneous drains were removed 14 days later. Postoperative complications were graded according to the Clavien-Dindo classification system.[12]
Calculation of financial data
All patient costs from admission to discharge, as captured daily into the hospital billing system, were accessed. The complete hospital charge sheet, as well as the invoices for laboratory investigations, radiology services and all specialist clinicians contributing to care, were reviewed and aggregated to calculate the total cost per patient. Costs were classified under the following categories: hospital bed costs, which were subdivided into general ward, ICU and high care; cost of ward consumables (swabs, dressings, intravenous cannulas and lines, etc); pharmacy costs; operating theatre costs (theatre time, consumables including sutures, anaesthetic gases, etc.); radiology costs; laboratory costs and specialist fees. The high inflation rate of healthcare expenditure in SA during the study period from 2002 to 2013 exceeded consumer price inflation, and necessitated adjustment of the calculated costs for each year to 2013 figures before
a meaningful statistical analysis could be performed. Costs were adjusted with data specific to medical inflation available from Statistics South Africa (www.statssa.gov.za).
Statistical analysis
Data were analysed with Microsoft Excel and results presented as percentages, medians, means and ranges. STATA version 11 was used to study the correlation between postoperative complications, sepsis on admission, conversion to open surgery upon recognition and cost of repair, by applying the χ2 test.
Results
During the study period, 44 patients (33 women, 11 men; median age 48 years, range 30 - 78) with major bile duct injuries were assessed and the injuries repaired (Table 1). The indication for laparoscopic cholecystectomy was symptomatic gallstones in 80% of patients and acute cholecystitis in 20%; 43% of injuries were recognised during the index operation. Patients were referred for evaluation and management of new injuries after a median of 14.5 days (range 1 3 662), and definitive repair was performed at a median of 24.5 days after injury (range 1 - 3 674). Nine repairs (26%) were done within 7 days of the injury, 6 (18%) between 7 and 14 days, 6 (18%) between 2 and 6 weeks and 13 (38%) after 6 weeks. Strictures of 10 previous repairs done elsewhere required reoperation at a median of 5 years (range 240 days - 16 years) after the initial repair. Patients spent a median of 15 days (range 6 - 86) in hospital, of which a median of 5.5 days (2 - 55) were in the high-care unit or ICU. There were no perioperative deaths. Two patients (5%) had Strasberg type C injuries, 6 (14%) type E1 injuries, 33 (75%) type E2 injuries, 2 (5%) type E3 injuries and 1 (2%) a type E4 injury. Theatre and ICU/high-care admission were the major
Table 1. Patient demographics (N=44) and general data Age (years), median (range)
48 (30 - 78)
Males, n (%)
11 (25.0)
Females, n (%)
33 (75.0)
Indication for cholecystectomy: uncomplicated symptomatic gallstones, n (%)
35 (79.5)
Indication for cholecystectomy: acute cholecystitis, n (%)
9 (20.4)
Injury recognised at cholecystectomy, n (%)
19 (43.2)
Injury not recognised at cholecystectomy, n (%)
25 (56.8)
Total days in hospital, median (range)
15 (6 - 86)
Days in ICU/high care, median (range)
5.5 (2 - 55)
Days in general ward, median (range)
9 (2 - 46)
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RESEARCH
factors and increased cost was not statistically significant, probably owing to type 2 statistical error. Fifteen postoperative complications occurred in 14 patients (32%), as shown in Table 4. Patients with postoperative compli cations spent a median of 23 total days in hospital, as opposed to a median of 13 total days in hospital for those without complications. On multivariate analysis, delay in referral did not appear to influence the cost of repair.
contributors to cost, accounting for 22% and 21% of the total costs of repair, respectively. The contributors to cost are summarised in Table 2. The inflation-adjusted mean total cost of repair was ZAR215 711 (range ZAR68 764 - 980 830). The data were scrutinised to detect factors that were responsible for increasing the cost of repairing new bile duct injuries. The correlations between the cost of repair and the presence of sepsis on admission (cholangitis, infected bilomas, biliary peritonitis), postoperative complications and conversion to open surgery after recognition at the index laparoscopic cholecystectomy are illustrated in Table 3. The association between these
Discussion
The benefits of laparoscopic over traditional open cholecystectomy include less postoperative pain, shorter hospital stay and smaller incisions, thus avoiding the sequelae of large abdominal
Table 2. Contributors to total cost of definitive repair Theatre
%
Mean cost (ZAR)
22.2
47 883
Bed (ICU/high care)
20.9
44 985
Radiology
17.3
37 259
Specialist fees
12.3
26 595
Bed (general ward)
9.9
21 322
Ward consumables
6.5
14 053
Pharmacy
5.0
10 785
Endoscopy
2.9
6 359
Laboratory
2.9
Total
6 469 215 711
Table 3. Factors associated with increased cost of repair n
Cost (ZAR) p-value
Mean cost of new repairs
34
230 452
Mean cost of revision surgery
10
165 589
Mean cost of new repair (recognised, not converted)
7
175 349
Mean cost of new repair (recognised, converted)
6
350 611
Mean cost without postoperative complications
35
208 606
Mean cost with postoperative complications (> grade 1 ClavienDindo[12])
9
243 338
Mean cost if presented with sepsis
10
317 949
Mean cost if presented without sepsis
34
185 641
0.44* 0.42*
0.43*
0.35*
*χ2 test.
Table 4. Summary of postoperative complications Grade according to Clavien-Dindo system[12]
n
Description
Grade 1
5
Wound sepsis
Grade 2
2
Wound sepsis
Grade 3a
2
Perihepatic abscess, perihepatic abscess
Grade 3b
3
Biloma, incisional hernia, early postoperative small-bowel obstruction
Grade 4
2
Myocardial infarction, cerebrovascular accident
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wall incisions.[1] The major disadvantage of the laparoscopic technique is the increased incidence of bile duct injuries, which may result in considerable morbidity.[1-4] Healthrelated quality of life after bile duct injury in comparison with uncomplicated laparoscopic cholecystectomy has been shown to be adversely affected as measured by psychological outcome, while physical outcomes appear to be similar.[13] Little information is available to accurately quantify the overall financial implications of a bile duct reconstruction, incorporating such diverse costs as loss of income due to time off work, travel expenses, medical fees, rehabilitation and possible litigation. Loss of income encompasses not only time away from work while in hospital, but also the convalescent period and follow-up visits and may extend to a partner or spouse involved in a supportive capacity who may need to travel long distances between home and the hospital where the repair is done. These costs are, by their very nature, difficult to calculate accurately and little information on medicolegal costs is available,[14] especially locally. The cost of definitive bile duct recon struction has been reported on previously,[8-10] with Savader et al.[8] reporting a mean cost of USD51 411 in 1995, ranging from 4.5 to 26.0 times the cost of an uncomplicated laparoscopic cholecystectomy. The cohort of 44 patients in our study who all had major bile duct injuries repaired by Roux-en-Y hepaticojejunostomy is unique with respect to the number of patients evaluated and the inclusion of all applicable costs plus adjustment for inflation, as well as inclusion of the time from hospital admission for the definitive repair to discharge. The mean cost of ZAR215 711 is substantial and is 6.4 times the cost of an uncomplicated laparoscopic cholecystectomy performed at the same institution. The most expensive repair in this study amounted to ZAR980 830, incorporating 86 days spent in hospital, which illustrates the potential impact of bile duct injuries and the high cost imposed on medical insurance and/or patients. Early recognition of bile duct injury and referral to a hepatobiliary surgeon are essential to reduce morbidity and ensure a satisfactory surgical outcome.[15] Yet in this study, 57% of injuries were only recognised after a median delay of 5 days, with 19 of 25 patients presenting with sepsis due to cholangitis or biliary peritonitis or septic bilomas, a finding similar to previously reported data.[7] These findings reinforce the maxim that all laparoscopic cholecystectomy patients require careful assessment and thorough investigation to exclude iatrogenic injury to the bile ducts in the event of any unexpected postoperative symptoms.
RESEARCH
For methodological reasons it was not possible to calculate costs incurred at the hospital where the injury occurred. Accumulated costs before referral were estimated to be substantial in some cases, including specialised imaging, attempted repair of the injury, or reoperation for intraperitoneal sepsis. Correlations with the cost of repair were studied with the aim of identifying those modifiable factors responsible for driving up the cost of repair. Intuitively, delayed recognition, sepsis and complications ought to have an adverse effect on the eventual outcome and cost of repairing a bile duct injury owing to increased length of ICU and hospital stay, increased imaging investigations and interventions to address intra-abdominal sepsis. However, these factors could not be proven to have a statistically significant effect on cost in this study. In conclusion, bile duct injuries after laparoscopic cholecystectomy remain a serious problem in modern surgical practice. There is general consensus that patients who require evaluation and repair of a bile duct injury should be referred to a specialised centre. The present study shows that in a tertiary academic centre, reconstructive surgery for complex iatrogenic laparoscopic bile duct injuries has acceptable morbidity and can be accomplished with no mortality. The costs incurred as a consequence of a bile duct injury are considerable and result in a substantial economic burden. The absolute aggregated cost of a bile duct repair is dependent on a variety of factors. This study reflects the experience of a high-volume referral centre, and extrapolation to other centres may not be applicable. As the consequences of a bile duct injury can be devastating, prevention must remain the top priority during laparoscopic cholecystectomy.
References 1. Smith JF, Boysen D, Tschirhart J, et al. Comparison of laparoscopic cholecystectomy versus elective open cholecystectomy. J Laparoendosc Surg 1992;2(6):311-317. [http://dx.doi.org/10.1089/lps.1992.2.311] 2. Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg 1995;189:101-125. 3. Richardson MC, Bell G, Fullarton GM. Incidence and nature of bile duct injuries following laparoscopic cholecystectomy: An audit of 5913 cases. Br J Surg 1996;83(10):1356-136. [http://dx.doi. org/10.1002/bjs.1800831009] 4. Nuzzo G, Giulante F, Giovannini I, et al. Bile duct injury during laparoscopic cholecystectomy: Results of an Italian national survey on 56 591 cholecystectomies. Arch Surg 2005;140(10):986-992. [http:// dx.doi.org/10.1001/archsurg.140.10.986] 5. De Reuver RP, Rauws EA, Vermeulen M, et al. Endoscopic treatment of post-surgical bile duct injuries: Long term outcome and predictors of success. Gut 2007;56(11):1599-1605. [http://dx.doi.org/10.1136/ gut.2007.123596] 6. Connor S, Garden OJ. Bile duct injury in the era of laparoscopic cholecystectomy. Br J Surg 2006;93(2):158-168. [http://dx.doi.org/10.1002/bjs.5266] 7. Sicklick JK, Camp MS, Lillemoe KD, et al. Surgical management of bile duct injuries sustained during laparoscopic cholecystectomy: Perioperative results in 200 patients. Ann Surg 2005;241(5):786-792. [http://dx.doi.org/10.1097/01.sla.0000161029.27410.71] 8. Savader SJ, Lillemoe KD, Prescott CA, et al. Laparoscopic cholecystectomy-related bile duct injuries: A health and financial disaster. Ann Surg 1997:225(3):268-273. [http://dx.doi.org/10.1097/00000658199703000-00005] 9. Andersson K, Eriksson K, Blind P. Iatrogenic bile duct injury â&#x20AC;&#x201C; a cost analysis. HPB 2008;10(6):416419. [http://dx.doi.org/10.1080/13651820802140745] 10. Woods MS. Estimated costs of biliary tract complications in laparoscopic cholecystectomy based upon Medicare cost/charge ratios: A case-control study. Surg Endosc 1996;10(10):1004-1007. [http://dx.doi. org/10.1007/s004649900224] 11. Terblanche J, Worthley CS, Spence RA, Krige JE. High or low hepaticojejunostomy for bile duct strictures. Surgery 1990;108(5):828-834. 12. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: A new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004:240(2):205-213. [http:// dx.doi.org/10.1097/01.sla.0000133083.54934.ae] 13. Landman MP, Feurer ID, Moore DE, et al. The long-term effect of bile duct injuries on health-related quality of life: A meta-analysis. HPB 2013;15(4):252-259. [http://dx.doi.org/10.1111/j.1477-2574.2012.00586.x] 14. Roy PG, Soonawalla ZF, Grant HW. Medicolegal costs of bile duct injuries incurred during laparoscopic cholecystectomy. HPB 2009;11(2):130-134. [http://dx.doi.org/10.1111/j.1477-2574.2008.00023.x) 15. Thomson BN, Parks RW, Madhavan KK, et al. Early specialist repair of biliary injury. Br J Surg 2006;93(2):216-220. [http://dx.doi.org/10.1002/bjs.5194]
Accepted 23 October 2014.
Prehospital cooling of severe burns: Experience of the Emergency Department at Edendale Hospital, KwaZulu-Natal, South Africa D Fiandeiro,1 MB ChB, FCEM (SA), Dip EC (SA), DA (SA); J Govindsamy,2 MB ChB, DA (SA); R C Maharaj,3 MB ChB, FCEM (SA), MMed (EM), Dip PEC (SA), DA (SA) epartment of Emergency Medicine, Edendale Hospital, Pietermaritzburg, South Africa D Burns Unit, Department of Surgery, Edendale Hospital, Pietermaritzburg, South Africa 3 Department of Emergency Medicine, King Dinizulu Hospital, Durban, South Africa 1 2
Corresponding author: D Fiandeiro (danielhasemail@gmail.com)
Background. Early cooling with 10 - 20 minutes of cool running water up to 3 hours after a burn has a direct impact on the depth of the burn and therefore on the clinical outcome of the injury. An assessment of the early cooling of burns is essential to improve this aspect of burns management. Objectives. To assess the rates and adequacy of prehospital cooling received by patients with severe burns before presentation to the Emergency Department (ED) at Edendale Hospital, Pietermaritzburg, South Africa. Patients with inadequate prehospital cooling who presented to the ED within 3 hours were also identified. Methods. A retrospective review of the burns database for all the patients with severe burns admitted from the ED at Edendale Hospital from September 2012 to August 2013 was undertaken. Demographic details, characteristics and timing of the burns, and presentation were correlated with burn cooling. Results. Ninety patients were admitted with severe burns. None received sufficient cooling of their burns, 25.6% received cooling of inadequate duration, and 32.3% arrived at the ED within 3 hours after the burn with either inadequate or no cooling. The median time to presentation to the ED after the burn was 260 minutes. Conclusion. Appropriate cooling of severe burns presenting to Edendale Hospital is inadequate. Education of the community and prehospital healthcare workers about the importance of early appropriate cooling of severe burns is required. Many patients would benefit from cooling of their burns in the ED, and facilities should be provided for this vital function. S Afr Med J 2015;105(6):457-460. DOI:10.7196/SAMJ.8705
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There is a high prevalence of burns in South Africa (SA), with approximately 3.2% of South Africans suffering thermal injuries each year.[1] Burns are also one of the leading causes of disability-adjusted life years lost in low- and middle-income countries.[2] Timeous access of burn patients to appropriate medical care is vitally important to improve prognosis. Current optimal burn first aid involves the application of cool running water for 10 - 20 minutes as soon as possible after the burn, although cooling up to 3 hours after a burn has been shown still to be beneficial.[3] Early cooling of burns leads to less clinical and histological tissue necrosis, improves burn healing and helps relieve pain.[3-5] In porcine studies, decreased histological burn depth was noted after 20 and 30 minutes of cooling over 5 and 10 minutes (p<0.05). [6] Delayed cooling of porcine burns for 1 or 3 hours also showed improved wound re-epithelialisation and decreased the amount of scar tissue that developed.[7] Burns with delayed cooling were also shown to have less necrosis than non-cooled burns. [4] Application of cool running water consistently demonstrated improvement in wound recovery compared with application of wet towels or cooling sprays (p<0.05).[8] Burns cooled with iced water showed increased necrosis.[4] In a study performed at the Royal Children’s Hospital in Brisbane, Australia, children who received 20 minutes of cooling had significantly reduced time to re-epithelialisation (p=0.011).[9] It is important to note that mortality is increased in hypothermic burn patients, as noted in a study performed in New York (60% v. 3%, p<0.001),[10] although the study showed that none of the patients who received prehospital cooling was found to be hypothermic.[10] The authors demonstrated that hypothermia was present in 35% of patients with a burn total body surface area (TBSA) of ≥70% and in 0.9% of patients with a TBSA of <70% (p<0.001), which would imply that extra caution should be exercised when cooling larger burns to avoid hypothermia. Improvement in burn care would have far-reaching implications on patients’ lives and on their communities, and any improvement in burn severity and depth would markedly affect hospital length of stay and use of hospital resources. The prehospital and emergency care of burns is an underemphasised responsibility of the healthcare system. Local and international studies confirm that prehospital management of burns is inadequate,[11-13] and the majority of acute burns are managed by emergency department (ED) staff without intervention by a burns specialist.[14]
Methods
A retrospective review of the burns database at Edendale Hospital, a large regional hospital in Pietermaritzburg, SA, for all patients with severe burns admitted to the burns unit and adult and paediatric intensive care units between September 2012 and August 2013 was undertaken. Edendale Hospital is a referral hospital for many local district hospitals, community health centres and clinics. It also covers a large local population who have direct access to the ED. The Edendale burns unit is a designated specialist-run service with a dedicated high-care burns unit and theatre slates for burn cases.
Data collection
Information was gathered on a burns admission proforma for all patients with burns requiring admission by the ED staff on arrival to the ED. The data were then added to the burns database by the burns registrar. Only cooling performed by the patient, their family, bystanders or prehospital staff was recorded. Cooling performed by
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the Edendale Hospital ED staff was not included. Duration of cooling with water was documented as per the report given by the patient. Variables assessed included age, gender, time of burn, day of week, burn mechanism, burn depth, and burn size in relation to prehospital cooling and time to presentation. Data were recorded on an Excel spreadsheet.
Inclusion criteria
Patients with severe burns, which were defined as >15% TBSA in adults, >10% TBSA in children, >5% TBSA full-thickness burns and inhalational injury, were included.
Exclusion criteria
Burns not fulfilling the criteria for severe burns were excluded.
Study measures and statistical analysis
The data were analysed using Intercooled Stata version 11. Pearson’s χ2 test and Fisher’s exact test were used to test whether there was any association between the various demographic factors and burn characteristics, and reception of cooling. The level of significance was set at p<0.05.
Ethics
Ethics approval was granted by the University of KwaZulu-Natal’s Biomedical Research and Ethics Committee (Ref. BE027/14). Approval was also received from the KwaZulu-Natal Provincial Health Research Committee and the management of Edendale Hospital.
Results
Ninety patients with severe burns were admitted during the period under review. Patient demographics and burn characteristics are set out in Table 1. Four patients with flame burns and one patient with chemical burns died as a result of their injuries. A further patient died as a result of systemic sepsis. Of the patients who died, two had received some form of cooling. No patient with severe burns presenting to the Edendale Hospital ED during the study period received adequate prehospital cooling, and only 25.6% of patients received any cooling with water, which was reported as <5 minutes of cooling. Only 32.3% of the patients presented to the ED within 3 hours of their burns. Table 2 depicts the correlation of burn characteristics with cooling. The correlation of time to presentation to the ED with the administration of prehospital cooling is set out in Table 3.
Discussion
The near-complete absence of adequate cooling is in keeping with the results of other studies, including a study performed at another large regional hospital in KwaZulu-Natal, which demonstrated that only 1.1% of their burn population received 10 minutes of cooling within 3 hours of the burn,[11] and a further 26% received cooling of inadequate duration.[11] Internationally, prehospital cooling also appears to be inadequate. Only 33.9% of burn patients presenting to a Shanghai hospital received ‘cooling therapy’ of any sort. Of these patients, 88% received less than 10 minutes of cooling.[12] Only 51% of patients presenting to a UK ED had irrigated their burns with cool running water, for unknown durations of time.[13] On further assessment of the 25.6% in our study who did receive some cooling, demographics and burn characteristics did not seem to have a significant impact on the application of prehospital cooling. With regard to mechanism of the burn, there was no difference in the
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reception of cooling. Flame-burnt patients received the same rates of cooling as hot water-burnt patients, and patients aged ≤12 years received the same rate of cooling as adults. In addition, seasonal Table 1. Patient demographics and burn characteristics Patients (N=90) Gender, n (%) Male
51 (57)
Female
39 (43)
Age (years), n (%) ≤12 (paediatric)
65 (72.2)
>12 (adult)
25 (27.8)
variation did not seem to impact significantly on prehospital cooling. A higher percentage of patients presenting to the ED during the day received some prehospital cooling, which was statistically significant. This could be attributed to easier access to water during the day and more layman assistance being available to the burn victim. However, this was a small sample and studies with a larger sample size need to be conducted. The fact that almost three-quarters of this cohort consisted of patients aged ≤12 years emphasises the need for parent education on burns prevention and first-aid treatment of burns. Inadequate parental knowledge of appropriate first aid for burns has been demonstrated in developed countries with relatively good access to Table 2. Correlation of burn characteristics with cooling (N=90)
Mechanism of burn No cooling n (%)
<5 minutes of cooling n (%)
Male
39 (76.5)
12 (23.5)
Female
28 (71.8)
11 (28.2)
≤12 (paediatric)
48 (73.9)
17 (26.1)
>12 (adult)
19 (76.0)
6 (24.0)
Water
57 (63.3)
Flame
23 (25.6)
Electrical
3 (3.3)
Gender
Chemical
1 (1.1)
Other
6 (6.7)
≤20
73 (81.1)
21 - 40
12 (13.3)
>40
0.614
Age (years)
TBSA (%), n (%)
5 (5.6)
Arrival to the ED
0.834
Mechanism of burn
0.547
Water
42 (73.7)
15 (26.3)
17 (73.9)
6 (26.1)
Day shift (07h00 - 19h00), n/N (%)
54/77 (70.1)
Flame
Night shift (19h00 - 07h00), n/N (%)
23/77 (29.9)
Electrical
3 (100.0)
-
13
Chemical
-
1 (100.0)
Other
5 (83.3)
1 (16.7)
Time not captured, n Season burn occurred, n (%)
TBSA of burn (%)
0.712
Spring (Sept - Nov)
22 (24.4)
Summer (Dec - Feb)
27 (30.0)
≤20
55 (75.3)
18 (24.7)
Autumn (Mar - May)
23 (25.6)
21 - 40
9 (75.0)
3 (25.0)
Winter (Jun - Aug)
18 (20.0)
>40
3 (60.0)
2 (40.0)
35/54 (64.8)
19/54 (35.2)
20/23 (87.0)
3/23 (13.0)
19 (86.4)
3 (13.6)
Time of burn*
Prehospital first aid, n (%) No first aid
59 (65.6)
Day (07h00 - 19h00)
Application of cool water
23 (25.6)
Egg
5 (5.5)
ight (19h00 N 07h00)
Ice
3 (3.3)
Cooling No cooling
67 (74.4)
Cooling <5 min
23 (25.6)
Cooling >5 min
-
Time to presentation to ED after burn ≤3 h, n/N (%)
20/62 (32.3)
>3 h, n/N (%)
42/62 (77.8)
Median time (min)
260
Missing data on times, n
14
Seen in another ED before referral to Edendale, n
14
Outcome at discharge from burns unit, n (%) Survived
84 (93.3)
Died
6 (6.7)
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0.049
Seasonal variation Spring (Sept - Nov)
p-value
0.529
Summer (Dec - Feb)
19 (70.4)
8 (29.6)
Autumn (Mar - May)
16 (69.6)
7 (30.4)
Winter (Jun - Aug)
13 (72.2)
5 (27.8)
*13 patients missing data on time of burn.
Table 3. Correlation of prehospital cooling with time of presentation to ED* ≤3 hours’ delay n/N (%)
>3 hours’ delay n/N (%)
13/43 (30.2)
30/43 (69.8)
≤5 minutes
7/19 (36.8)
12/19 (63.2)
>5 minutes
-
-
No cooling
*14 patients missing data on time of burn or arrival, 14 admitted elsewhere prior to transfer.
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information and resources.[15] In a survey of parents who presented to a university hospital in the UK, only 32% had adequate knowledge of first aid for burns, and a further 40% had no or poor knowledge.[15] It was noted that parents who had attended a first-aid course performed better and that parents from lower socioeconomic groups fared worse, which may also be a factor in our study. Only 10% of parents attending the outpatient clinic at Sheffield Children’s Hospital in the UK would give ideal first aid for a burn, with only 35% cooling the burn for an adequate period of time.[16] The median delay to presentation to the emergency department of 260 minutes after the burn was less than the time noted in Ngwelezane Hospital in northern KwaZulu-Natal.[11] This may be attributed to patients being closer to the hospital, possibly more accessible transport, or better prehospital emergency response infrastructure in our setting compared with the more rural setting of the other study. With nearly a third of patients presenting to the ED within 3 hours of their burns without cooling, there is a large group who would still have benefited from burn first aid in the ED. This highlights the need for burn first-aid awareness on the part of ED staff as well, and appropriate facilities and protocols should be developed to address the issue. Dedicated taps or showers should be fitted in EDs to cool burns. Burns could also be cooled in the ED by using a jug and large basins. Wet towels have been shown to be less effective than running water, but their use may be more practical for larger burns. With many burn patients being referred from primary healthcare clinics and others being transferred by paramedics, there is an even larger percentage who are having even earlier contact with medical professionals and would benefit from cooling of their burns. In a prospective study conducted in Western Australia, it was noted that the first medical contact was responsible for inappropriate first aid for burns in half of the patients.[17] In a study in the UK assessing different healthcare workers, 23% suggested applying ice to burns, which has been shown to be detrimental to their progression.[18] The authors concluded that knowledge of burn first aid on the part of healthcare providers is universally poor. Attendance at a first-aid course by healthcare providers improved the knowledge of burn first aid.[19] This further demonstrates the need for education of prehospital and primary healthcare medical staff on appropriate burns management, as they are usually the first point of medical contact for burn patients. Burn first-aid knowledge of the prehospital staff in our context needs to be assessed further. Attendance at first-aid courses and refresher burns courses should be encouraged to improve knowledge of initial burn care. Amendments to the burns management protocols of the paramedic services should include appropriate prehospital cooling of burns. Modified methods of cooling with a jug and basin may need to be implemented if no running water is readily available. Further assessment into the reasons why the rate of cooling is so low in these patients needs to be performed. Possible reasons may include lack of awareness of the benefits of cooling and inappropriate facilities or resources to best cool burns. While primary prevention of burns is considered the ideal, significant reduction in mortality
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and morbidity can be achieved if treatment of burns is commenced early. This requires a team-based approach to management of burns and includes public education, easy access to medical care and early initiation of appropriate first aid. Public awareness campaigns should focus on burn prevention and safety, and on administering immediate, appropriate first aid after a burn.
Study limitations
This was a retrospective review of a database that relied on the accuracy of the data recorded. Missing data in the database could have influenced the accuracy of our findings.
Conclusion
It is evident that the first aid for patients with burns who present to Edendale Hospital is poor, and there is a need for widespread firstaid training of healthcare workers and the community. There needs to be a concerted effort to provide earlier access to healthcare for this community, and quality first-aid treatment for burns must be provided to patients who present to the Edendale ED early. References 1. Matzopoulos RE. A Profile of Fatal Injuries in South Africa: Fifth Annual Report of the National Injury, Mortality Surveillance System. Cape Town: University of Cape Town and MRC Crime, Violence and Injury Lead Program, 2004. 2. World Health Organization. World Media Fact Sheet. http://www.who.int/mediacentre/factsheets/ fs365/en (accessed 4 June 2014). 3. Cuttle L, Kimble RM. First aid treatment of burn injuries. Wound Practice and Research 2010;18(1):613. [http://dx.doi.org/10.1016/j.burns.2008.10.011] 4. Venter THJ, Karpelowsky JS, Rode H. Cooling of the burn wound: The ideal temperature of the coolant. Burns 2007;33(7):917-922. [http://dx.doi.org/10.1016/j.burns.2006.10.408] 5. Lonecker S, Schoder V. Hypothermia in patients with burn injuries: Influence of prehospital treatment. Chirurg 2001;72(2):164-167. [http://dx.doi.org/10.1007/s001040051286] 6. Bartlett, N, Yuan, J, Holland AJA, et al. Optimal duration of cooling for an acute scald contact burn injury in a porcine model. J Burn Care Res 2008;29(5):828-834. [http://dx.doi.org/10.1097/BCR.0b013e3181855c9a] 7. Cuttle L, Kempf M, Liu P-Y, Kravchuk O, Kimble RM. The optimal duration and delay of first aid treatment for deep partial thickness burn injuries. Burns 2009:36(5):673-679. [http://dx.doi. org/10.1016/j.burns.2009.08.002] 8. Yuan J, Wu C, Holland AJA, et al. Assessment of cooling on an acute scald burn injury in a porcine model. J Burn Care Res 2007;28(3):514-520. [http://dx.doi.org/10.1097/BCR.0b013e3181855c9a] 9. Cuttle L, Kravchuk O, Wallis B, Kimble RM. An audit of first-aid treatment of pediatric burns patients and their clinical outcome. J Burn Care Res 2009;30(4):828-834. [http://dx.doi.org/10.1097/ BCR.0b013e3181bfb7d1] 10. Singer AJ, Taira BR, Thode HC jr, et al. The association between hypothermia, prehospital cooling, and mortality in burn victims. Acad Emerg Med 2010;17(4):456-459. [http://dx.doi.org/10.1111/j.15532712.2010.00702.x] 11. Scheven D, Barker P, Govindsamy J. Burns in rural Kwa-Zulu Natal: Epidemiology and the need for community health education. Burns 2012;38(8):1224-1230. [http://dx.doi.org/10.1016/j.burns.2012.04.001] 12. Ji S, Luo P, Kong Z, et al. Prehospital emergency burn management in Shanghai: Analysis of 1868 burn patients. Burns 2012;38(8):1174-1180. [http://dx.doi.org/10.1016/j.burns.2012.03.010] 13. Khan AA, Rawlins J, Shenton AF, Sharpe DT. The Bradford burn study: The epidemiology of burns presenting to an inner city emergency department. Emerg Med J 2007;24(8):564-566. [http://dx.doi. org/10.1136/emj.2005.027730] 14. DeKoning EP, Hakeneworth A, Platts-Mills TF, Tintinalli JE. Epidemiology of burn injuries presenting to North Carolina emergency departments in 2006-2007. Burns 2009;35(6):776-782. [http://dx.doi. org/10.1016/j.burns.2008.09.012] 15. Davies M, Maguire S, Okolie C, Watkins W, Kemp AM. How much do parents know about first aid for burns? Burns 2013;39(6):1083-1090. [http://dx.doi.org/10.1016/j.burns.2012.12.015] 16. Graham HE, Sarah E, Bache SE, Muthayya P, Baker J, Ralston DR. Are parents in the UK equipped to provide adequate burns first aid? Burns 2012;38(3):438-443. [http://dx.doi.org/10.1016/j.burns.2011.08.016] 17. Rea S, Kuthubutheen J, Fowler B, Wood F. Burn first aid in Western Australia – do healthcare workers have the knowledge? Burns 2005;31(8):1029-1034. [http://dx.doi.org/10.1016/j.burns.2005.05.010] 18. Tay PH, Pinder R, Coulson S, Rawlins J. First impressions last … a survey of knowledge of first aid in burn-related injuries amongst hospital workers. Burns 2013;39(2):291-299. [http://dx.doi. org/10.1016/j.burns.2012.05.013] 19. Skinner A, Peat B. Burns treatment for children and adults: A study of initial burns first aid and hospital care. N Z Med J 2002;115(1163):1-9. [http://dx.doi.org/10.1016/j.burns.2013.02.007]
Accepted 21 April 2015.
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Paediatric dental chair sedation: An audit of current practice in Gauteng, South Africa F Bham,1 MB BCh, DA (SA); H Perrie,1 MSc; J Scribante,1 MCur; C-A Lee,2 MB ChB, FCA (SA), MMed (Anaesthesiol) 1 2
Department of Anaesthesiology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Private practice, Johannesburg, South Africa
Corresponding author: F Bham (faizalbham@gmail.com)
Background. Procedural sedation and analgesia (PSA) is often required to perform dental procedures in children. Serious adverse outcomes, while rare, are usually preventable. Objectives. To determine the proportion of dental practitioners making use of paediatric dental chair PSA in Gauteng Province, South Africa, describe their PSA practice, and determine compliance with recommended safety standards. Method. A prospective, contextual, descriptive study design was used, with 222 randomly selected dental practitioners contacted to determine whether they offered paediatric dental chair PSA. Practitioners offering PSA were then asked to complete a web-based questionnaire assessing their practice. Results. Of the 213 dental practitioners contacted, 94 (44.1%; 95% confidence interval 37 - 51) provided PSA to children. Most patients were 1 - 5 years old, although there were practices that offered PSA to infants. While most procedures were performed under minimal to moderate sedation, deep sedation and general anaesthesia were also administered in dental rooms. Midazolam was the most frequently used sedative agent, often in conjunction with inhaled nitrous oxide; 28.1% of PSA providers administered a combination of three or more agents. Presedation patient assessment was documented in 83.0% of cases, and informed consent for sedation was obtained in 75.6%. The survey raised several areas of concern regarding patient safety: 41.3% of dental practices did not use any monitoring equipment during sedation; the operator was responsible for the sedation and monitoring of the patient in 41.3%; 43.2% did not keep any recommended emergency drugs; and 19.6% did not have any emergency or resuscitation equipment available. Most respondents (81.8%) indicated an interest in sedation training. Conclusion. Paediatric dental chair PSA was offered by 44.1% of dental practitioners interviewed in Gauteng. Modalities of PSA provided varied between practices, with a number of safety concerns being raised. S Afr Med J 2015;105(6):461-464. DOI:10.7196/SAMJ.8788
Procedural sedation and analgesia (PSA) is generally safe, and is often necessary to facilitate dental procedures in children. If provided in dental rooms, PSA is cost-effective, avoiding the expenses generated by having to perform procedures in operating theatres. It allows the dentist to practise in the familiarity of his or her own rooms,[1] and overcomes the need to rely on the limited availability of anaesthetists. Dental chair PSA should not, however, be performed at the cost of patient safety. While serious adverse events, including death and permanent neurological injury, occur rarely, they are nearly always preventable. Tragically, these adverse outcomes have been reported in healthy children sedated for minor procedures, suggesting the need to adopt guidelines that could reduce the risk associated with PSA.[2] A USA-based critical incident analysis of 118 reported serious adverse paediatric sedation events revealed that, while respiratory compromise was the initial event in over 80% of adverse events, regardless of whether a child was sedated in or out of hospital, a final outcome of death or permanent neurological injury occurred more frequently in an out-ofhospital than an in-hospital setting (92.8% of events v. 37.2%; p<0.001). The most common contributory cause was drug interactions, implicated in 46.3% of events. Drug overdose, inadequate monitoring, inadequate resuscitation, inadequate medical evaluation and premature discharge were also shown to be causes contributing to these events, some of which occurred at home or on the way to or from the facility (sedatives were sometimes being prescribed to give at home before leaving for the procedure). Reports like these led to the widespread development of guidelines for safe procedural sedation.[3]
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The South African Society of Anaesthesiologists (SASA) published a guideline for the safe use of procedural sedation and analgesia for diagnostic and therapeutic procedures in children in 2010 (SASA PSA guideline).[4] The aim of the guideline is to provide a reference to enable all medical practitioners, including dentists, to act within a framework that ensures patient safety and to provide safe sedation, analgesia and anxiolysis in all environments. The guideline provides guidance on patient selection, recommended drugs and dosages, equipment, monitoring, documentation and discharge criteria.[4] The World Health Organization (WHO) has identified the need for research aimed at improving patient safety as a priority, especially in developing and transitional countries.[5] No previously published data were identified on the percentage of dental practices in Gauteng utilising PSA and whether sedation practitioners are aware of the available SASA PSA guideline.[4] Comparing data with recommended safety standards may identify areas of concern and serve as a guide to developing measures that will enhance safety during paediatric dental chair sedation.
Objectives
To determine the proportion of dental practitioners making use of paediatric dental chair PSA in Gauteng, and to describe their practice and adherence to the SASA PSA guideline.[4]
Methods
Approval to conduct this study was obtained from the Human Research Ethics Committee (Medical) of the University of the Witwatersrand, Johannesburg.
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RESEARCH
A prospective, contextual, descriptive study design was used. The study population comprised qualified dental practitioners listed on the South African Dental Association website and practising in Gauteng. The names and contact numbers of 1 152 practitioners were available to the public on the website on 23 June 2012.[6] Two hundred and twentytwo of them were selected by simple random sampling and invited telephonically to participate in the study. The sample size was determined in consultation with a biostatistician and influenced by available resources (financial and time constraints) and the scope of the study. Practitioners who consented to participate and whose practice provided dental chair PSA to children up to 12 years old were then sent an introductory email with a link to a webbased questionnaire. The questionnaire was designed using SurveyMonkey, a commercial online survey site. Before developing the questionnaire, the relevant literature was reviewed to identify the potential safety pitfalls in the field of paediatric dental chair PSA. The SASA PSA guideline[4] served as the main reference point for the development of the questionnaire (content validity), which assessed items in the following categories: the professional category of the person responsible for administering PSA; modalities of sedation administered; awareness of the SASA PSA guideline;[4] training of the sedationist; patient selection; monitoring; and emergency equipment and drugs. The questionnaire was developed in consultation with three experts in the field (face validity). Confidentiality and anonymity of information were ensured, as all responses were uploaded anonymously onto the SurveyMonkey website for analysis and the researchers were the only people with access to this database by way of a user name and password. A reminder was emailed to all participants 2 weeks after the initial email to thank those practitioners who had completed the questionnaire and to serve as a reminder to those who had not yet done so. The following definitions were used in this study, consistent with those used in the SASA PSA guideline: • Minimal sedation and anxiolysis. The patient responds normally to verbal commands. Cognitive function and co-ordination may be impaired, but ventilation and cardiovascular function are unaffected.[4] • Moderate sedation and analgesia. Depression of consciousness during which the patient can respond purposefully
to verbal commands, either alone or accompanied by light tactile stimulation. The patient is able to maintain a patent airway and spontaneous ventilation.[4] • Deep sedation and analgesia. The patient cannot easily be roused, but may respond purposefully following repeated or painful stimulation. Assistance may be required to maintain a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.[4] • General anaesthesia. Patients cannot be roused, even by painful stimulation. Patients require assistance in maintaining a patent airway and positive-pressure ventilation may be required. Cardiovascular function may be impaired.[4] Descriptive statistics using frequencies and percentages were used to analyse the data. A 95% confidence interval (CI) was reported for the proportion of dental practitioners interviewed who used paediatric dental chair PSA.
Results
Two hundred and twenty-two dental practitioners were contacted telephonically between April and May 2013. Nine were excluded from the study because they were no longer in clinical practice. Data analysis therefore included 213 dental practitioners, comprising 195 general dentists and 18 specialists (6 orthodontists, 5 periodontists, 4 maxillofacial surgeons and 3 prosthodontists). Ninety-four of the 213 dental practitioners interviewed offered paediatric dental chair PSA as part of their routine practice (44.1%; 95% CI 37 - 51). The participant information letter containing a link to the questionnaire was sent to 93 of the 94 practitioners, as one respondent did not have an email address. Of the 93 questionnaires issued, 52 (55.9%) were returned to the SurveyMonkey database for further analysis. Certain questions in the questionnaire were omitted by some respondents, with no clear pattern of omissions emerging. Table 1 presents the professional categories of PSA providers. Of the 48 respondents to this question, 22 indicated that they were primarily responsible for PSA administration in their practice (45.8%). Of these, 12 (54.6%) had received sedation training and 4 (20%) were aware of the SASA PSA guideline.[4] Thirty-six of 44 respondents (81.8%) were interested in attending a sedation course. Forty-eight respondents indicated the route(s) of drug administration and depth(s)
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of sedation administered in their rooms. These results are broken down into professional categories of PSA providers and illustrated in Figs 1 and 2, respectively. Drugs were most commonly given orally (n=25, 52.1%), although the intravenous (n=22, 45.8%), inhalational (n=20, 41.7%), and intramuscular (n=1, 2.1%) routes were also used. Twenty-seven practitioners (56.3%) performed procedures under minimal sedation and 25 (52.1%) utilised moderate sedation. Deep sedation (n=5, 10.4%) and general anaesthesia (n=1; 2.1%) were provided in fewer dental rooms. Thirty-two dental practitioners indicated the number of agents used in combination during PSA. Table 2 presents these data. Midazolam, nitrous oxide (N₂O) and propofol were the most popular agents used for sedation, used in 68.8%, 39.6% and 27.1% of practices, respectively. The 1 - 5- and 6 - 8-year-old age groups were most commonly sedated (76.6% and 74.5% of 47 dental practices, respectively), followed by the 9 - 12-year-old age group (20 practices, 42.6%). Two dental practitioners performed procedures under PSA in infants. Table 1. Professional category of person primarily responsible for administering PSA
Responsible person
Dental practices n (%)
Dental practitioner*
22 (45.8)
Qualified nurse
-
Medical practitioner
1 (2.1)
Medical practitioner with sedation training
15 (31.3)
Anaesthetist
10 (20.8)
Total
48 (100.0)
*The practitioner performing the dental procedure.
Table 2. Number of sedative agents used in combination
Number of agents
Dental practices n/N (%)*
1
10/32 (31.3)
2
13/32 (40.6)
3
8/32 (25.0)
≥4
1/32 (3.1)
Respondent unaware
6 (-)
Total
38
*Percentage of dental practices in which the dental practitioner was aware of the combination used.
RESEARCH
Presedation assessment was conducted in 83.0% of practices, with 75.6% obtaining informed consent prior to providing PSA. Forty-six respondents indicated the monitoring equipment used during PSA and the emergency equipment available for management of any adverse events. Tables 3 and 4 present these data. The dental practitioner was the person responsible for the sedation and monitoring of children in 41.3% of practices. No monitoring equipment was used in 41.3% of practices. Oxygen was available in 36 practices (78.3%), with 14 practices (30.4%) having emergency airway equipment. Of the 44 dental practitioners who indicated which emergency drug(s) were available during PSA procedures, 19 (43.2%) did not keep any emergency drugs, 25
Table 3. Monitoring equipment used during PSA
(56.8%) kept adrenaline, 14 (31.8%) stocked atropine, 8 (18.2%) had succinylcholine, 6 (13.6%) had flumazenil, and 5 (11.4%) kept naloxone. Flumazenil was stocked by 5 (15.2%) of the 33 respondents who used midazolam and by 1 (10.0%) of the 10 diazepam users. Naloxone was stocked by 1 of the 5 respondents who used alfentanil (20.0%), but by none of the practices in which fentanyl (2), pethidine (1) or tilidine (1) were administered. Of the 20 respondents who were primarily responsible for providing PSA in their rooms, 18 (90.0%) had received Basic Life Support training and 2 (10.0%) had Advanced Paediatric Life Support certification. A staffed recovery area was available in 60.5% of practices. Apart from one report of an allergic reaction, no serious adverse events or complications were reported in this survey.
Discussion
While no significant adverse events or complications were reported during this audit of current practice in Gauteng, some of
Pulse oximetry
25/46 (54.3)
Non-invasive blood pressure
16/46 (34.8)
16
Sedation monitoring chart
14/46 (30.4)
14
Electrocardiogram
14/46 (30.4)
12
Capnography
4/46 (8.7)
Praecordial stethoscope
4/46 (8.7)
Thermometer
4/46 (8.7)
None of the above
19/46 (41.3)
Dental practices, n
Equipment
Dental practices n/N (%)
Oxygen supply
36/46 (78.3)
Face masks
33/46 (71.7)
Bag-valve ventilation device
22/46 (47.8)
OPAs or NPAs
16/46 (34.8)
Intravenous fluids
16/46 (34.8)
Laryngoscope set
14/46 (30.4)
Endotracheal tubes
14/46 (30.4)
Intravenous cannulas
14/46 (30.4)
Glucose testing machine
10/46 (21.7)
Defibrillator
8/46 (17.4)
ETCO₂ monitoring
2/46 (4.4)
None of the above
9/46 (19.6)
Dental practitioner* Medical practitioner with sedation training*
8 6
0
6
5
4
Medical practitioner* 3
2
1
2
Oral (n=25)
1
1
Intravenous (n=22)
2
11
Inhalation (n=25)
1
PSA provider not indicated*
Intramuscular (n=25)
Route of administration
Fig. 1. Routes of PSA drug administration and the professional category of PSA providers. 25 Dental practices, n
Equipment
Dental practices n/N (%)
13
10
4
Table 4. Equipment available for management of adverse events
Anaesthetist*
14
13
the findings raise concerns about the safety of children being sedated for procedures in the dental chair. In this study, 45.8% of PSA was provided by the dental practitioner, who was also the operator. Patients receiving PSA were being monitored by the dental practitioner in 41.3% of practices. The SASA guideline states that even for basic sedation (which includes the administration of inhaled N2O or oral midazolam), ‘someone other than the operator must be responsible for monitoring the patient’. If these agents are used together, the sedation technique is considered to be advanced, in which case ‘someone other than the operator must be responsible for the administration of sedation, monitoring of vital signs and, should complications of sedation arise, rescue of the patient’.[4] Deep sedation and general anaesthesia were less commonly administered than minimal and moderate sedation in this study. The distinction in depth is important, as the complication rate associated with planned mild to moderate sedation is lower than that with deep sedation (3.8% v. 9.2%; odds
20
Anaesthetist* 20 Dental practitioner*
15
13
10 5 0
OPAs or NPAs = oropharyngeal airways or nasopharyngeal airways; ETCO₂ = end-tidal carbon dioxide.
Medical practitioner with sedation training*
8 2
3
Medical practitioner*
4
2
11
Minimal sedation (n=27)
Moderate sedation (n=25)
1
2
Deep sedation (n=5)
1 General anaesthesia (n=1)
PSA provider not indicated*
Depth of sedation
Fig. 2. Depth of sedation used for dental chair PSA and the professional category of PSA providers.
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RESEARCH
ratio 2.6).[2] The SASA PSA guideline[4] suggests that deep sedation and general anaesthesia should only be performed by those with anaesthetic training, in recognition of this increased risk. It is important to recognise, however, that the planes of sedation are difficult to predict, and that children can easily ‘move’ from moderate to deep sedation, with its attendant complications. For that reason, both a human ‘monitor’ and essential monitoring equipment are recommended, and any child receiving advanced sedation (i.e. more than one agent) should be fasted as per recommended guidelines for deep sedation or anaesthesia. It is recommended that all patients receiving PSA be monitored using pulse oximetry. Pulse oximetry, electrocardiography and non-invasive blood pressure monitoring are considered minimum monitoring for advanced sedation, with capnography recommended.[4] Of the practices surveyed in this report, 54.4% used pulse oximeters, but 41.3% did not use any form of monitoring equipment during PSA. This is in contrast to the 19% of North American practices that were found not to use pulse oximetry and the 5% that did not use any monitoring during PSA.[7] Sedation should only be performed in an environment capable of handling emergencies.[4] While most dental practitioners in this study who provide PSA had Basic Life Support training, 43.2% of practices did not keep any of the recommended emergency or antidotal drugs in stock and 19.6% did not have any emergency equipment available. Midazolam was the most frequently used sedative agent for paediatric dental chair PSA, while N₂O was the most common agent administered in practices in which the dental practitioner was primarily responsible for PSA provision. Although N₂O is generally considered to be safe, any agent can depress the patient’s ability to respond normally to airway obstruction once the drug depresses the central nervous system.[8,9] Three or more sedative agents were combined in 28.1% of dental practices providing PSA. The potential for adverse outcomes is significantly increased when three or more drugs with sedative properties are combined.[3,4,10] This does not mean that drugs should not be combined, but emphasises the need for adequate monitoring and availability of emergency equipment when a combination of sedative agents is administered, as inadequate monitoring and equipment have been identified as being among the contributory causes of sedation-related adverse events.[4] Drugs for PSA were most frequently given orally in this study (52.1%). There should nevertheless be a uniform level of vigilance, as any sedative has the potential to cause respiratory depression regardless of its route of administration.[10] Indeed, a review of paediatric dental sedation adverse effects from closed malpractice claims showed that 10 of 13 sedation claims involved administration of oral sedation.[11] The majority of respondents (76.6%) in this study offered PSA to children <6 years of age. This is the age group most likely to require sedation to facilitate surgery, but also the group most vulnerable to the adverse effects associated with sedative medication.[11,12] Two dental practitioners indicated that they performed procedures under PSA in infants. An increased incidence of adverse sedation events in infants compared with other age groups has been reported,[13] and the SASA PSA guideline suggests that such patients should preferably be sedated in a hospital setting.[4] Several dental practitioners gave further insights into issues they had encountered in the provision of PSA in the dental chair. Some are practical – people reported a limitation of both theatre time and the availability of anaesthetists to perform procedures in theatre. There are also financial considerations – participants commented on the reluctance of medical aid schemes to pay anaesthetists for dental chair sedation or to cover the extra costs associated with performing dental procedures in theatre. Despite this, some practitioners made use of the theatre setting as they were of the opinion that dental room sedation was ‘too risky’.
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It was highlighted that despite appreciating the risks associated with PSA, it is neither realistic nor necessary to restrict its provision to anaesthetists, who are insufficient in number to cater for the ever-increasing need for paediatric PSA.[9,14,15] Several practitioners indicated that they would like to offer PSA in their rooms, but felt that they first required training to be able to do so.
Conclusion
Performing dental procedures in children is often not possible without the aid of PSA, which if provided in dental rooms is cost-effective and overcomes the need to rely on the limited availability of anaesthetists. Patient safety should not, however, be compromised in any way. Paediatric dental chair PSA was offered by 44.1% of dental practitioners interviewed in Gauteng. The modalities of PSA provided varied between dental practices, with many facilities not adhering to recommended safety standards. Particular areas of concern identified in this study were the high proportion of practices in which no monitoring equipment, emergency equipment or emergency drugs were available. More than 80% of the practitioners surveyed indicated an interest in attending sedation training, suggesting a desire to learn safe sedation techniques and comply with safety requirements. Increased emphasis on such training and promoting awareness of the PSA guideline may improve adherence to recommended safety standards. We hope that this information will serve as a starting point to developing measures that will enhance safety during paediatric dental chair PSA in South Africa. We encourage the South African anaesthetic and dental communities to work together to achieve this. Disclaimer. The views expressed in this article are those of the authors and not an official position of the University of the Witwatersrand. Source of support. Department of Anaesthesiology, University of the Witwatersrand. Acknowledgement. This study fulfilled part of FB’s course requirements for an MMed (Anaesthesiol) degree at the University of the Witwatersrand. References 1. Roelofse JA. What’s new in paediatric conscious sedation in dentistry? SAAD Dig 2010;26:3-7. 2. Hoffman GM, Nowakowski R, Troshynski TJ, Berens RJ, Weisman SJ. Risk reduction in pediatric procedural sedation by application of an American Academy of Pediatrics/American Society of Anesthesiologists process model. Pediatrics 2002;109(2):236-243. [http://dx.doi.org/10.1542/ peds.109.2.236] 3. Cote CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: A critical incident analysis of contributing factors. Pediatrics 2000;105(4):805-814. [http://dx.doi. org/10.1542/peds.105.4.805] 4. South African Society of Anaesthesiologists. Guidelines for the safe use of procedural sedation and analgesia for diagnostic and therapeutic procedures in children. South Afr J Anaesth Analg 2010;16(5 Suppl):S1-S37. 5. World Health Organization. WHO Patient Safety Research. France: World Health Organization, 2009 (WHO/IER/PSP/2009.10). 6. South African Dental Association. Find a practitioner. 2012. http://www.sada.co.za/d_findpractitioner. asp. (accessed 23 June 2012). 7. Goodchild JH, Donaldson M. The use of sedation in the dental outpatient setting: A web-based survey of dentists. Dent Implantol Update 2011;22(11):73-80. 8. Vade A, Sukhani R, Dolenga M, Habisohn-Schuck C. Chloral hydrate sedation of children undergoing CT and MR imaging: Safety as judged by American Academy of Pediatrics guidelines. AJR Am J Roentgenol 1995;165(4):905-909. [http://dx.doi.org/10.2214/ajr.165.4.7676990] 9. Cote CJ. Monitoring guidelines: Do they make a difference? AJR Am J Roentgenol 1995;165(4):910912. [http://dx.doi.org/10.2214/ajr.165.4.7676991] 10. Cote CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: Analysis of medications used for sedation. Pediatrics 2000;106(4):633-444. [http://dx.doi.org/10.1542/ peds.106.4.633] 11. Chicka MC, Dembo JB, Mathu-Muju KR, Nash DA, Bush HM. Adverse events during pediatric dental anesthesia and sedation: A review of closed malpractice insurance claims. Pediatr Dent 2012;34(3):231-238. 12. Lee HH, Milgrom P, Starks H, Burke W. Trends in death associated with pediatric dental sedation and general anesthesia. Paediatr Anaesth 2013;23(8):741-746. [http://dx.doi.org/10.1111/pan.12210] 13. Malviya S, Voepel-Lewis T, Tait AR. Adverse events and risk factors associated with the sedation of children by nonanesthesiologists. Anesth Analg 1997;85(6):1207-1213. [http://dx.doi. org/10.1097/00000539-199712000-00005] 14. Krauss B, Green SM. Training and credentialing in procedural sedation and analgesia in children: Lessons from the United States model. Paediatr Anaesth 2008;18(1):30-35. [http://dx.doi.org/10.1111/ j.1460-9592.2007.02406.x] 15. Smallman B. Pediatric sedation: Can it be safely performed by non-anesthesiologists? Curr Opin Anaesthesiol 2002;15(4):455-9. [http://dx.doi.org/10.1097/00001503-200208000-00008]
Accepted 21 April 2015.
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RESEARCH
The South African Surgical Outcomes Study: A 7-day prospective observational cohort study B M Biccard,1 PhD; T E Madiba,2 PhD; on behalf of the South African Surgical Outcomes Study investigators iscipline of Anaesthesiology and Critical Care, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela D School of Medicine, University of KwaZulu-Natal, Durban, South Africa 2 Department of Surgery, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa 1
Corresponding author: B Biccard (biccardb@ukzn.ac.za)
Background. Non-cardiac surgical morbidity and mortality is a major global public health burden. Sub-Saharan African perioperative outcome data are scarce. South Africa (SA) faces a unique public health challenge, engulfed as it is by four simultaneous epidemics: (i) poverty-related diseases; (ii) non-communicable diseases; (iii) HIV and related diseases; and (iv) injury and violence. Understanding the effects of these epidemics on perioperative outcomes may provide an important perspective on the surgical health of the country. Objectives. To investigate the perioperative mortality and need for critical care admission in patients undergoing inpatient non-cardiac surgery in SA. Methods. A 7-day national, multicentre, prospective, observational cohort study of all patients ≥16 years of age undergoing inpatient noncardiac surgery between 19 and 26 May 2014 at 50 public sector, government-funded hospitals in SA. Results. The study included 3 927/4 021 eligible patients (97.7%) recruited, with 45/50 hospitals (90.0%) submitting data that described all eligible patients. Crude in-hospital mortality was 123/3 927 (3.1%; 95% confidence interval (CI) 2.6 - 3.7). The rate of postoperative admission to critical care units was 255/3 927 (6.5%; 95% CI 5.7 - 7.3), with 43.5% of admissions being unplanned. Of the surgical procedures 2 120/3 915 (54.2%) were urgent or emergency ones, with a population-attributable risk for mortality of 25.5% (95% CI 5.1 55.8) and a risk of admission to critical care of 23.7% (95% CI 4.7 - 51.4). Conclusions. Most patients in SA’s public sector hospitals undergo urgent and emergency surgery, which is strongly associated with mortality and unplanned critical care admissions. Non-communicable diseases have a larger proportional contribution to mortality than infections and injuries. However, the most common comorbidity, HIV infection, was not associated with in-hospital mortality. The study was registered on ClinicalTrials.gov (NCT02141867). S Afr Med J 2015;105(6):465-475. DOI:10.7196/SAMJ.9435
Non-cardiac surgery represents a major global public health burden,[1] with a postoperative mortality rate of 2 - 4%.[2,3] Surgery is cost-effective, however,[4] and a core component of health.[5] Surgical outcomes were well described in Europe in the European Surgical Outcomes Study (EuSOS).[3] These data cannot be extrapolated to South Africa (SA), as the country has a lower human development index than Europe and different population morbidity patterns. SA faces four simultaneous major epidemics: (i) poverty-related diseases; (ii) non-communicable diseases (NCDs); (iii) HIV and related diseases; and (iv) injury and violence.[6] In SA, perioperative outcome data are scarce.[7] The Global Burden of Disease Study[8] suggests a proportionally larger contribution of communicable diseases to perioperative mortality compared with Europe, and a lesser contribution of NCDs. The contribution of HIV to perioperative outcomes is unclear.[9] The above provided the rationale to conduct a study similar to EuSOS in SA, known as the South African Surgical Outcomes Study (SASOS). The primary outcome was in-hospital mortality. Secondary outcomes included duration of hospital stay, rate of admission to critical care following surgery, and duration of critical care stay. In order to understand the proportional contribution of communicable diseases, NCDs and injuries to surgical outcomes, these variables were also added to the adopted EuSOS dataset. Risk factors associated with in-hospital mortality and critical care admissions were also explored.
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Methods
This was a 7-day, SA national multicentre prospective observational cohort study of patients aged ≥16 years undergoing inpatient noncardiac surgery. The study was registered on ClinicalTrials.gov (NCT02141867). Departments of anaesthesia, surgery, critical care and gynaecology affiliated to all the medical schools in SA agreed to participate. A sample of 50 participating hospitals was obtained by approaching all the hospitals in which training by these academic departments took place. Additional hospitals were recruited through professional contacts. All SA provinces were represented. Hospital-specific data were collected, including number of operating rooms and number and level of critical care beds. Ethics approval was obtained for all sites. The ethics review board of each medical school (University of Cape Town, University of the Free State, University of KwaZuluNatal, University of Limpopo, University of Pretoria, Stellenbosch University, University of the Witwatersrand (Wits) and Walter Sisulu University) approved the study. For the majority of sites, a waiver of consent was approved. Wits and the Free State Provincial Administration stipulated that informed consent be required from all patients, with deferred consent for patients who could not give consent prior to surgery. Wits stipulated that only patients aged ≥18 years could consent to participate. The intention was to recruit all eligible patients in order to minimise data selection bias.
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RESEARCH
Recruitment ran from 07h00 on 19 May 2014 to 06h59 on 26 May. Eligible patients included all patients aged ≥16 years (with the exception of the Wits hospitals) undergoing elective or non-elective inpatient noncardiac surgery during the 7-day recruitment period. Exclusions were planned day surgery, cardiac surgery, radiological procedures not requiring anaesthesia, and obstetric patients. Recruitment preoperatively, and follow-up until discharge, were performed by local investigators. The study was censored at 30 days postoperatively for patients still in hospital. The EuSOS dataset was adopted with minor changes. The major deviation from the EuSOS protocol, as recommended by the EuSOS steering committee, was to censor the study at 30 days as opposed to 60 days because most of the deaths in EuSOS occurred within 30 days of surgery. The same potential risk factors as in EuSOS were collected for in-hospital mortality and critical care mortality, but the primary indication for surgery, based on the categories of communicable diseases, NCDs and injuries, was added. Neurosurgical patients were included. To ensure consistency in data definitions and interpretation, the principal investigators (BMB and TEM) made site visits to meet with local investigators and provide study educational material. The website provided educational support and a regularly updated ‘frequently asked questions’ web page. The case report forms (CRFs) are available on the study website (www.sasos.co.za). Data were collected on paper CRFs and were pseudoanonymised by unique numerical codes generated during data transcription onto an internet-based CRF. Each patient could only be identified on the electronic CRF by their numerical code. The co-ordinating study team could not trace data back to an individual patient without contact with the local team. Access to the data entry system was username and password protected. All electronic data transfer was encrypted using a secure protocol. The study was reported according to the STROBE statement.[10]
could therefore include up to 30 variables in logistical regression models for mortality and critical care admission.[11] The data collected were all part of routine clinical care. Categorical variables were described as proportions and compared using χ2 tests, Fisher’s exact tests, Pearson’s χ2 tests or χ2 tests with Yates’s correction, as appropriate. Continuous variables were described as means and standard deviations (SDs) if normally distributed, or otherwise as medians and interquartile ranges (IQRs). Comparisons of continuous variables between groups were performed using unpaired t-tests or one-way analysis of variance, as appropriate. Univariate analysis was performed to test for risk factors associated with critical care admission and/ or in-hospital death. Generalised linear mixed models using a logit link were used to identify independent risk factors for binary outcomes. These included one-level, hierarchical two-level and three-level models to account for the expected correlation in outcomes within hospitals and provinces. We used a threelevel generalised mixed model, with patients being at the first level, hospital at the second and province at the third. We excluded patients with missing values for potential risk predictors, and only used complete case analysis as <4% of the dataset was incomplete for a potential clinical risk predictor.[12] Results were reported as adjusted odds ratios (ORs) with 95% confidence intervals (CIs). All factors with a univariate association of p<0.05 were entered into the models. The exception was diabetes, which was not entered into the mortality
Results
SASOS included 50 government-funded hospitals: 8 district hospitals, 41 regional or tertiary hospitals and 1 specialised services hospital. These hospitals had a median of 5 (IQR 4 - 8) operating rooms. Critical care units were available in 44/50 hospitals (88.0%). These units provided a median of 7 (IQR 4 -16) critical care beds, with a median of 6 (IQR 2 - 10) beds with access to mechanical ventilation and 3 (IQR 0 - 6) without mechanical ventilation. The study recruitment is shown in the flow diagram in Fig. 1. The overall recruitment was 3 927/4 021 of eligible patients (97.7%), with 45/50 hospitals
3 937 patients entered into database 8 duplicates removed 3 929 patients available for inclusion 2 missing outcome data
Statistical analysis
Based on expected surgical volumes submitted to the steering committee from the participating hospitals, we believed that it would be possible to generate a sample size close to 7 500 patients during a 7-day recruitment period. We assumed the same mortality rate as that for EuSOS (4%)[3] and an admission rate to critical care of half that in EuSOS (4% v. 8%, respectively). [3] We
model because we identified confounding between diabetes, American Society of Anesthesiologists (ASA) category and age. In the critical care admission regression, as nine of the 14 surgical categories had univariate associations with critical care admission, we entered a single surgical categorical variable into the regression. The average population-attributable risk (PAR) for variables associated with the outcomes was calculated[13] for a singlelevel model. Univariate and multivariate statistical analyses were performed using Statistical Package for the Social Sciences (SPSS) version 21 (SPSS Inc., USA). R statistical software package version 3.0.2 (R Foundation for Statistical Computing, Austria) was used to compute the PARs. All contingency table comparisons and unpaired t-tests between SASOS and EuSOS data were conducted using GraphPad Software Online Calculators (Graphpad Software Inc., USA).
3 927 patients included in analysis
255 critical care admissions, 144 planned and 111 unplanned Fig. 1. CONSORT diagram for survival analysis and critical care admission.
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RESEARCH Table 1. Description of cohort*
Age (years), mean (SD)
All patients (N=3 927)
Alive (N=3 804)
Died (N=123)
OR (95% CI)
p-value
43.5 (17.6)
43.3 (17.6)
52.1 (17.7)
1.03 (1.02 - 1.04)
<0.001
Male, n (%)
1 994 (50.8)
1 923 (50.6)
71 (57.7)
1.33 (0.93 - 1.2)
0.12
Current smoker, n (%)
1 083 (28.2)
1 057 (28.4)
26 (23.0)
0.75 (0.48 - 1.12)
0.21
1
1 743 (44.7)
1 731 (45.8)
12 (9.8)
Reference
2
1 347 (34.6)
1 318 (34.9)
29 (23.8)
3.18 (1.61 - 6.24)
<0.001
3
663 (17.0)
623 (16.5)
40 (32.8)
9.26 (4.83 - 17.77)
<0.001
4
131 (3.4)
94 (2.5)
37 (30.3)
56.78 (28.67 - 112.46)
<0.001
5
14 (0.4)
10 (0.3)
4 (3.3)
57.70 (15.87 - 209.84)
<0.001
Minor
1 403 (36.1)
1 387 (36.8)
16 (13.2)
Reference
Intermediate
1 672 (43.0)
1 627 (43.2)
45 (37.2)
2.40 (1.35 - 4.26)
0.003
Major
810 (20.8)
750 (19.9)
60 (49.6)
6.94 (3.97 - 6.94)
<0.001
Elective
1 795 (45.8)
1 770 (46.7)
25 (20.3)
Reference
Urgent
1 290 (33.0)
1 248 (32.9)
42 (34.1)
2.38 (1.45 - 3.93) 5.12 (3.17 - 8.27)
ASA category, n (%)
Grade of surgery, n (%)
Urgency of surgery, n (%)
Emergency
0.001
830 (21.2)
774 (20.4)
56 (45.5)
159 (4.1)
159 (4.2)
0 (0.0)
Orthopaedic
1 112 (28.4)
1 100 (29.0)
12 (9.8)
0.22 (0.11 - 0.45)
<0.001
Breast
109 (2.8)
108 (2.8)
1 (0.8)
0.19 (0.03 - 1.41)
0.10
Gynaecology
525 (13.4)
523 (13.8)
2 (1.6)
0.08 (0.02 - 0.33)
0.001
Vascular
134 (3.4)
125 (3.3)
9 (7.3)
1.47 (0.67 - 3.24)
0.34
Upper GIT
154 (3.9)
136 (3.6)
18 (14.6)
2.70 (1.42 - 5.11)
0.002
Lower GIT
400 (10.2)
376 (9.9)
24 (19.5)
1.30 (0.73 - 2.33)
0.38
Hepatobiliary
88 (2.2)
84 (2.2)
4 (3.3)
0.97 (0.33 - 2.87)
0.96
Plastics
242 (6.2)
235 (6.2)
7 (5.7)
0.61 (0.26 - 1.43)
0.25
Urology
212 (5.4)
208 (5.5)
4 (3.3)
0.39 (0.13 - 1.14)
0.25
Kidney
13 (0.3)
13 (0.3)
0 (0.0)
Head and neck
222 (5.7)
216 (5.7)
6 (4.9)
0.57 (0.23 - 1.40)
0.22
Neurosurgery
133 (3.4)
122 (3.2)
11 (8.9)
1.84 (0.88 - 3.85)
0.11
Thoracic
65 (1.7)
64 (1.7)
1 (0.8)
0.32 (0.04 - 2.39)
0.32
Other
513 (13.1)
489 (12.9)
24 (19.5)
Reference
Non-communicable
1 881 (48.1)
1 832 (48.3)
49 (39.8)
Reference
Injury
1 297 (33.1)
1 253 (33.1)
44 (35.8)
1.31 (0.87 - 1.99)
0.29
Infective
736 (18.8)
706 (18.6)
30 (24.4)
1.59 (1.00 - 2.52)
0.05
Coronary artery disease
160 (4.1)
152 (4.1)
8 (6.7)
1.71 (0.82 - 3.56)
0.16
Congestive heart failure
55 (1.4)
52 (1.4)
3 (2.5)
1.84 (0.57 - 5.98)
0.31
Diabetes mellitus (no insulin)
225 (5.8)
217 (5.8)
8 (6.7)
1.18 (0.57 - 2.44)
0.67
Diabetes mellitus with insulin therapy
171 (4.4)
160 (4.3)
11 (9.2)
2.29 (1.21 - 4.34)
0.01
Metastatic cancer
101 (2.6)
89 (2.4)
12 (10.1)
4.61 (2.45 - 8.69)
<0.001
Cirrhosis
7 (0.2)
6 (0.2)
1 (0.8)
5.29 (0.63 - 44.27)
0.12
Stroke or TIA
55 (1.4)
47 (1.3)
8 (6.7)
5.68 (2.62 - 12.30)
<0.001
COPD/asthma
240 (6.2)
230 (6.1)
10 (8.4)
1.40 (0.73 - 2.72)
0.31
HIV-positive/AIDS
509 (13.2)
498 (13.3)
11 (9.2)
0.67 (0.36 - 1.25)
0.67
Laparoscopic surgery, n (%)
<0.001 0.01
Surgical specialty, n (%)
0.52
Primary indication for surgery, n (%)
Comorbid disorder, n (%)
GIT = gastrointestinal; TIA = transient ischaemic attack; COPD = chronic obstructive pulmonary disease. *Data are mean (SD) or n (proportion). The denominator of the proportion is the number of cases that reported the risk factor. ORs were constructed for in-hospital mortality with univariate binary logistic regression analysis.
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RESEARCH
(90.0%) submitting data on all eligible patients. The patient characteristics and univariate associations with in-hospital mortality are shown in Table 1. Of the patients, 131/3 927 (3.3%) had missing clinical risk predictor data for in-hospital mortality. The in-hospital mortality rate was 123/3 927 (3.1%; 95% CI 2.6 - 3.7). There were no deaths at the district hospitals (0/255) and 122/3 624 deaths (3.1%; 95% CI 2.5 - 3.7) at the regional and tertiary hospitals. The highest hospital mortality was 9.5%. The median duration of hospital stay was 3 days (IQR 1 - 6). The rate of postoperative admission to critical care was 255/3 927 (6.5%; 95% CI 5.7 - 7.3), with 144/3 927 (3.7%; 95% CI 3.1 - 4.3) admissions planned and 111/3 927 (2.8%; 95% CI 2.3 - 3.3) unplanned; 111/255 (43.5%) critical care admissions were un planned. More patients were admitted to critical care in the regional and tertiary hospitals (248/3 625, 6.8%) than in the district hospitals (7/255, 2.7%; p=0.008). Sixty-six of the patients who died (53.7%) were not admitted to critical care. Critical care mortality was 57/255 (22.4%). Patients who had unplanned admissions to critical care had a signifi cantly higher mortality than those with planned admissions (37/111 (33.3%) v. 20/144 (13.9%), respectively; p<0.001) (Fig. 2). The median duration of critical care stay was 3 days (IQR 1 - 7). The generalised linear model for in-hospital mortality and the associated PAR for inde pendent risk factors are shown in Table 2. The univariate associations with critical care admissions are shown in Table 3. Of the patients, 132/3 927 (3.4%) had missing clinical risk predictor data for critical care admission. The generalised linear model for critical care admission and the associated PAR for independent risk factors are shown in Table 4. Comparisons between the SASOS data and the EuSOS data[3] are shown in Table 5. The mortalities were not compared as the outcome durations were different, and we could not risk-adjust for the differences in comorbidities between the populations.
Discussion
Principal findings
The SASOS in-hospital mortality was 3.1%, with 6.5% of surgical patients having been admitted to a critical care unit. The median duration of hospital stay was 3 days (IQR 1 - 6) and that of critical care 3 days (IQR 1 7). Most surgery was urgent or emergency (2 120/3 915, 66.4%). Urgent and emergency surgery represented a significant PAR for
Table 2. Three-level generalised linear model for in-hospital mortality
Age (years)
OR* (95% CI)
p-value
One-level PAR % (95% CI)
1.02 (1.01 - 1.04)
0.001
NS
ASA category 1
Reference
39.3 (12.4 - 77.1)
2
2.95 (1.41 - 6.17)
0.004
3
5.18 (2.48 - 10.86)
<0.001
4
22.09 (9.87 - 49.46)
<0.001
5
15.51 (3.43 - 70.25)
<0.001
Grade of surgery Minor
Reference
24.2 (4.2 - 53.9)
Intermediate
1.74 (0.94 - 3.24)
0.08
Major
3.21 (1.70 - 6.07)
<0.001
Urgency of surgery Elective
Reference
Urgent
2.10 (1.17 - 3.75)
0.01
25.5 (5.1 - 55.8)
Emergency
2.53 (1.39 - 4.58)
0.002
Orthopaedic
0.20 (0.10 - 0.42)
<0.001
Gynaecology
0.24 (0.06 - 1.03)
0.54
Upper GIT
2.14 (1.15 - 3.99)
0.02
3.6 (0.3 - 9.7)
Surgical specialty
Primary indication for surgery Non-communicable
Reference
Infective
1.89 (1.06 - 3.38)
0.03
NS
Injury
3.35 (1.87 - 6.02)
<0.001
NS
Metastatic cancer
2.96 (1.39 - 6.29)
0.01
2.2 (0.2 - 5.8)
Stroke or TIA
2.82 (1.09 - 7.32)
0.03
1.8 (0.1 - 4.7)
Comorbid disorder
GIT = gastrointestinal; TIA = transient ischaemic attack; NS = not significant at a single-level regression. *ORs were constructed for in-hospital mortality with a three-level generalised linear model.
mortality (25.5%; 95% CI 5.1 - 55.8) and critical care admission (23.7%; 95% CI 4.7 51.4). Unplanned critical care admission had a significantly higher associated mortality than planned admission. The SASOS data suggest that NCDs (reflected by metastatic cancers and stroke) have a larger proportional contribution to mortality than communicable diseases and injuries. When compared with the EuSOS data, SASOS patients were significantly younger and there were fewer non-communicable risk factors. The most common comorbidity was HIV infection, although it was not associated with in-hospital mortality. SASOS patients underwent significantly more urgent and emergency surgery (p<0.0001). Although SASOS patients had a significantly lower rate of critical care admissions than those in EuSOS (6.5%; 95% CI 5.7 - 7.3 v. 7.7%; 95% CI 7.5 - 8.0), they had significantly more unplanned critical
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care admissions (p<0.0001). SASOS patients spent longer in critical care than EuSOS patients (3 days; IQR 1 - 7 v. 1.2 days; IQR 0.9 - 3.6, respectively).
Strengths and weaknesses of SASOS
The strengths of this study are that it included all the government-funded, public sector, tertiary hospitals in SA, 41/74 (55.4%) of the government-funded regional hospitals, and 50/410 (12.2%) of all government-funded hospitals.[14] SASOS is therefore possibly generalisable to government-funded regional and tertiary hospitals in SA. By adopting the EuSOS protocol with minor modifications, SASOS provides data that are directly comparable with the EuSOS data and 28 European countries. This has important implications for generating consistent outcomes data for the Commission for Global Surgery. These are the first data from SA.
51 (4.0%); 5 deaths (9.8%) Stay in critical care 2 days (1 - 8) Hospital stay 10 days (5 - 27) 1 739 (96.9%); 22 deaths (1.3%) Hospital stay 2 days (1 - 4)
469
43 (2.4%); 1 death (2.3%) Stay in critical care 2 days (1 - 3) Hospital stay 6 days (4 - 14)
Fig. 2. Planned and unplanned admission to a critical care unit according to urgency of surgery. Data are n (%) or median (IQR). Data describing the first critical care admission for any individual patient were collected. The data presented do not describe readmission to critical care. Because of incomplete data for admission planning, two admissions to critical care are not presented in this figure. (Elective = not immediately lifesaving, planned within months or weeks; Urgent = planned surgery within hours or days of the decision to operate; Emergency = as soon as possible, no delay to plan care, ideally within 24 hours.)
715 (8.6%); 18 deaths (2.5%) Hospital stay 4 days (2 - 7) 49 (5.9%); 14 deaths (28.6%) Stay in critical care 3 days (2 - 7) Hospital stay 12 days (6 - 25)
Unplanned admission to critical care 66 (8.0%); 24 deaths (36.4%) Stay in critical care 4 days (2 - 11) Hospital stay 15 days (7 - 24) No admission Unplanned admission to critical to critical care care 1 208 (93.6%); 31 (2.4%); 26 deaths (2.2%) 11 deaths (35.5%) Hospital stay Stay in critical care 3 days 4 days (2 - 19) (1 - 7) Hospital stay 18 days (10 - 30) Planned admission to critical care No admission to critical care
Unplanned admission to critical care 13 (0.7%); 2 deaths (8.0%) Stay in critical care 4 days (1 - 7) Hospital stay 8 days (2 - 23) Planned admission to critical care
Urgent surgery 1 290 (32.8%) 42 deaths (3.3%) Elective surgery 1 795 (45.7%) 25 deaths (1.4%)
SASOS cohort 3 915 (99.7%) 123 deaths (3.1%)
Planned admission to critical care
Emergency surgery 830 (21.1%) 56 deaths (6.7%)
No admission to critical care
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Furthermore, this is the first study that has addressed the proportional contribution of the burden of disease categories (communicable diseases, NCDs and injuries) to perioperative mortality. The independent risk factors for in-hospital mortality were similar to those in EuSOS, suggesting that these risk factors are globally consistent. These risk factors are dominated by NCDs. As a result, the NCD burden contributes most to perioperative mortality. The SASOS data also provide external validation of the importance of non-communicable risk factors for perioperative mortality. Potential weaknesses of the study are that it only included 8/259 (3.1%) of the district hospitals in SA.[14] It is inappropriate to extrapolate the SASOS data to district hospitals, as although surgery may be limited in district hospitals, it is possible that the mortality is higher owing to limited resources, unmet surgical needs and a lack of provision for predominantly emergency surgery.[15] SASOS also only provides data from government-funded public sector hospitals in SA. It is possible that the burden of disease, case mix, prior health status, surgical techniques and outcomes may differ in the private sector hospitals.
Interpretation of the study
Based on the estimates of surgical volumes in SA by Weiser et al.,[1] the SA population statistics for 2013[16] and the SASOS data, the estimated mortality of surgery in adults (â&#x2030;Ľ20 years of age) in SA is between 76 and 128 deaths per 100 000, which is equivalent to 7.2% and 12.1% of all deaths in the country. It is inappropriate to directly compare the mortality rate between SASOS and EuSOS, as SASOS was censored at 30 days, and the SASOS patients had significantly fewer comorbidities that are established as risk factors for perioperative mortality. As the crude mortality rates for SASOS and EuSOS are similar, it is possible that a risk-adjusted mortality rate for surgery may be higher in SA. SASOS suggests that the benefits associated with surgery[4] are compromised for a number of reasons. The contributing SA hospitals had on average fewer operating rooms and critical care beds than reported in EuSOS, even though the majority of the hospitals in SASOS were regional and tertiary hospitals. This may have contributed to the finding that over 50% of patients who died were not admitted to a critical care unit. The potential benefits of surgery were further compromised by predominantly urgent and emergency surgery, resulting in more unplanned critical care admissions,
RESEARCH
Table 3. Critical care admission No critical care admission (N=3 672)
Any critical care admission (N=255)
p-value
Planned critical care admission (N=144)
Unplanned critical care admission (N=111)
ORâ&#x20AC; (95% CI)
p-value
Age (years), mean (SD)
43.5 (17.7)
43.7 (16.7)
Male, n (%)*
1 835 (50.0)
159 (62.4)
1.00 (0.99 - 1.01)
0.89
45.7 (17.0)
41.1 (15.9)
0.03
1.66 (1.27 - 2.15)
<0.001
84 (58.3)
75 (67.6)
0.15
Smoker, n (%)
1 015(28.2)
67 (28.5)
1.02 (0.76 - 1.36)
0.92
41 (30.4)
26 (26.0)
0.56
1 696 (46.6)
46 (18.1)
Reference
21 (14.6)
25 (22.7)
0.07
ASA category, n (%) 1 2
1 300 (35.7)
47 (18.5)
1.34 (0.88 - 2.01)
0.17
31 (21.5)
16 (14.5)
3
561 (15.4)
102 (40.2)
6.70 (4.67 - 9.62)
<0.001
62 (43.1)
40 (36.4)
4
78 (2.1)
53 (20.9)
25.05 (15.89 - 39.51)
<0.001
29 (20.1)
24 (21.8)
5
8 (0.2)
6 (2.4)
27.65 (9.22 - 82.93)
<0.001
1 (0.7)
5 (4.5)
1 382 (38.0)
21 (8.4)
Reference
10 (7.1)
11 (10.1)
Grade of surgery, n (%) Minor Intermediate
1 596 (43.9)
76 (30.4)
3.13 (1.92 - 5.11)
<0.001
37 (26.2)
39 (35.8)
Major
659 (18.1)
153 (61.2)
15.33 (9.62 - 24.41)
<0.001
94 (66.7)
59 (54.1)
Elective
1 738 (47.5)
56 (22.1)
Reference
43 (30.1)
13 (11.8)
Urgent
1 208 (33.0)
82 (32.4)
2.11 (1.49 - 2.98)
<0.001
51 (35.7)
31 (28.2)
0.13
Urgency of surgery, n (%)
Emergency
<0.001
715 (19.5)
115 (45.5)
4.99 (3.59 - 6.95)
<0.001
49 (34.3)
66 (60.0)
150 (4.1)
8 (3.2)
0.78 (0.38 - 1.61)
0.50
5 (3.5)
3 (2.8)
0.74
1 089 (29.7)
23 (9.1)
0.47 (0.26 - 0.85)
0.01
10 (7.0)
13 (11.7)
0.20
Breast
109 (3.0)
0 (0.0)
1.00
0 (0.0)
0 (0.0)
Gynaecology
515 (14.0)
10 (4.0)
0.43 (0.20 - 0.92)
0.03
3 (2.1)
7 (6.3)
Laparoscopic surgery, n (%) Surgical specialty, n (%) Orthopaedic
0.09
Vascular
113 (3.1)
21 (8.3)
4.14 (2.2 - 7.79)
<0.001
10 (7.0)
11 (9.9)
0.49
Upper GIT
122 (3.3)
32 (12.6)
5.84 (3.28 - 10.41)
<0.001
15 (10.6)
17 (15.3)
0.26
Lower GIT
364 (9.9)
36 (14.2)
2.20 (1.27 - 3.81)
0.01
18 (12.7)
18 (16.2)
0.47
Hepatobiliary
80 (2.2)
8 (3.2)
2.23 (0.96 - 5.18)
0.06
5 (3.5)
3 (2.7)
0.73
Plastics
233 (6.4)
9 (3.6)
0.86 (0.39 - 1.90)
0.71
6 (4.2)
3 (2.7)
0.53
Urology
202 (5.5)
10 (4.0)
1.10 (0.51 - 2.37)
0.80
8 (5.6)
2 (1.8)
0.13
Kidney
12 (0.3)
1 (0.4)
1.86 (0.23 - 14.92)
0.56
1 (0.7)
0 (0.0)
0.38
Head and neck
203 (5.5)
19 (7.5)
2.09 (1.10 - 3.94)
0.02
13 (9.2)
6 (5.4)
0.34
Neurosurgery
88 (2.4)
45 (17.8)
11.39 (6.52 - 19.90)
<0.001
32 (22.5)
13 (11.7)
0.03
<0.001
Thoracic
48 (1.3)
17 (6.7)
7.89 (3.92 - 15.87)
14 (9.9)
3 (2.7)
0.04
Other
490 (13.4)
22 (8.7)
Reference
7 (4.9)
15 (13.5)
0.02
1 775 (48.5)
105 (41.5)
Reference
74 (52.1)
31 (27.9)
<0.001
Primary indication for surgery, n (%) Non-communicable Injury
1 194 (32.6)
103 (40.7)
1.44 (1.09 - 1.92)
0.01
46 (32.4)
57 (51.4)
Infective
691 (18.9)
45 (17.8)
1.11 (0.78 - 1.60)
0.56
22 (15.5)
23 (20.7)
Comorbid disorder Coronary artery disease
145 (4.0)
15 (6.1)
1.56 (0.90 - 2.71)
0.11
12 (8.7)
3 (2.8)
0.06
Congestive heart failure
47 (1.3)
8 (3.3)
2.57 (1.20 - 5.50)
0.02
5 (3.6)
3 (2.8)
0.72
Diabetes mellitus (no insulin)
209 (5.8)
16 (6.5)
1.14 (0.68 - 1.93)
0.62
8 (5.8)
8 (7.5)
0.61
Diabetes mellitus with insulin therapy
163 (4.5)
8 (3.3)
0.72 (0.35 - 1.48)
0.37
1 (0.7)
7 (6.5)
0.01 Continued ...
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Table 3. (continued) Critical care admission No critical care admission (N=3 672)
Any critical care admission (N=255)
p-value
Planned critical care admission (N=144)
Unplanned critical care admission (N=111)
ORâ&#x20AC; (95% CI)
p-value
Metastatic cancer
90 (2.5)
11 (4.5)
1.85 (0.97 - 3.50)
0.06
8 (5.8)
3 (2.8)
0.26
Cirrhosis
6 (0.2)
1 (0.4)
2.47 (0.30 - 20.60)
0.40
1 (0.7)
0 (0.0)
0.38
Stroke or TIA
50 (1.4)
5 (2.0)
1.49 (0.59 - 3.77)
0.40
1 (0.7)
4 (3.7)
0.10
COPD/asthma
212 (5.9)
28 (11.4)
2.08 (1.37 - 3.15)
0.001
19 (13.8)
9 (8.4)
0.23
HIV-positive/AIDS
489 (13.5)
20 (8.2)
0.57 (0.36 - 0.91)
0.02
11 (8.0)
9 (8.4)
1.00
GIT = gastrointestinal; TIA = transient ischaemic attack; COPD = chronic obstructive pulmonary disease. *The denominators of the proportions are the number of cases that reported the risk factor. â&#x20AC; ORs were constructed for in-hospital mortality with univariate binary logistic regression analysis.
Table 4. Three-level generalised linear model for critical care admission
Male
OR* (95% CI)
p-value
1.15 (0.81 - 1.65)
0.44
PAR % (95% CI)
ASA category 1
Reference
26.1 (5.4 - 55.7)
2
1.78 (1.10 - 2.88)
0.02
3
5.87 (3.73 - 9.24)
<0.001
4
13.82 (7.74 - 24.70)
<0.001
5
7.18 (1.88 - 27.38)
<0.001
Grade of surgery Minor
Reference
Intermediate
2.55 (1.47 - 4.42)
0.001
35.3 (9.5 - 70.8)
Major
10.93 (6.29 - 18.97)
<0.001
Urgency of surgery Elective
Reference
Urgent
2.57 (1.65 - 3.99)
<0.001
23.7 (4.7 - 51.4)
Emergency
3.19 (2.07 - 4.93)
<0.001
0.25 (0.12 - 0.53)
<0.001
Surgical specialty Orthopaedic Breast
1.00
Gynaecology
0.63 (0.26 - 1.54)
0.31
Vascular
0.91 (0.42 - 1.96)
0.80
Upper GIT
2.36 (1.18 - 4.73)
0.02
Lower GIT
1.17 (0.60 - 2.27)
0.65
Hepatobiliary
2.39 (0.87 - 6.59)
0.09
Plastics
1.10 (0.45 - 2.66)
0.84
Urology
1.28 (0.53 - 3.07)
0.58
Kidney
0.67 (0.07 - 6.36)
0.73
Head and neck
2.40 (1.13 - 5.12)
0.02
2.3 (0.4 - 5.1)
3.5 (0.4 - 8.6)
Neurosurgery
3.49 (1.75 - 6.98)
<0.001
5.9 (0.7 - 13.9)
Thoracic
2.90 (1.20 - 7.05)
0.02
NS
Other
Reference Continued ...
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June 2015, Vol. 105, No. 6
an associated increased mortality, longer critical care stay, and therefore less critical care resources for patients. Urgency of surgery has a far larger proportional contribution to perioperative mortality than other preoperative surgical risk factors. Importantly, the mortality and critical care admission rate associated with urgent and emergency surgery are mainly due to factors other than injuries and violence, as injuries have little or no contribution to the attributable risk in SASOS. The importance of the PAR is that it quantifies the proportion of cases that can be attributed to a risk factor,[13] which permits stratification of preventive public health interventions on the outcome. The majority of urgent and emergency surgery occurs across all surgical disciplines and comorbidities, and late presentation of patients for surgery in SA contributes significantly to surgical morbidity and mortality. This is important in strategic planning to provide safe surgery in SA. The SASOS data suggest that NCDs have a larger proportional contribution to morbidity and mortality than infections and injuries. The contribution of NCDs to perioperative mortality in SA may be expected to increase as a result of epidemiological transition[17] and the success of HIV therapy in increasing life expectancy.[18] The SASOS data suggest that the SA health budget needs to allocate more funding: (i) to primary healthcare to identify and manage potential surgical pathologies; and (ii) to hospital and tertiary healthcare services to provide sufficient surgical and critical care services to decrease surgical morbidity and mortality. The need for urgent and emergency surgery may have arisen from a number of factors, including: (i) poor primary healthcare and late detection of surgical pathology; (ii) poor medical management of
RESEARCH
Table 4. (continued) Three-level generalised linear model for critical care admission OR* (95% CI)
p-value
PAR % (95% CI)
NS
Primary indication for surgery Other
Reference
Injury
2.18 (1.46 - 3.27)
<0.001
Congestive heart failure
1.16 (0.45 - 2.96)
0.76
COPD/asthma
0.96 (0.56 - 1.64)
0.87
HIV-positive/AIDS
0.56 (0.32 - 0.98)
0.043
Comorbid disorder
GIT = gastrointestinal; COPD = chronic obstructive pulmonary disease; NS = not significant at a single-level regression. *ORs were constructed for critical care admission with a three-level generalised linear model.
Table 5. Comparison between SASOS and EuSOS data SASOS (N=3 927)
EuSOS (N=44 657)
p-value
Age, mean (SD)
43.5 (17.6)
56.7 (18.5)
<0.0001
ASA 1, n (%)
1 743 (44.7)
11 642 (26.1)
<0.0001
Elective surgery, n (%)
1 795 (45.8)
35 049 (78.5)
<0.0001
Minor surgery, n (%)
1 403 (36.1)
12 041 (27.0)
<0.0001
1
Orthopaedic 1 112 (28.4)*
Orthopaedic 12 214 (27.4)
2
Gynaecology 525 (13.4)†
Head and neck 5 640 (12.6)
3
Lower gastrointestinal 400 (10.2)*
Lower gastrointestinal 4 972 (11.1)
4
Plastics 242 (6.2)*
Urology 4 881 (10.9)
5
Head and neck 222 (5.7)†
Gynaecology 3 972 (8.9)
Risk predictors
Most common surgeries by rank, n (%)
Conclusion
In order to realise the full benefits of surgery in SA, it is important that a proactive strategy be adopted to increase surgical and critical care resources. Strategies aimed at decreasing the burden of urgent and emergent surgery should be implemented. Funding disclosure. The study was funded by the South African Society of Anaesthesiologists and the Vascular Association of South Africa. The study website was maintained by the Anaesthesia Network for South Africa. They had no role in the study design, data acquisition, data analysis or writing up of the paper. Conflicts of interest and source of funding. T M Esterhuizen and R M R Moreno received payment for statistical analyses for SASOS from SASOS grant funds for the submitted work, and R M Pearse (RMP) received grants and personal fees from Nestlé Health Sciences, personal fees from Massimo Inc., personal fees from Edwards Lifesciences and grants and non-financial support from LiDCO Ltd that might have an interest in the submitted work in the previous 3 years. RMP was first author of EuSOS and A Hoeft, R Moreno and A Rhodes were authors of EuSOS. The remainder of the authors have nothing to disclose.
Most common comorbidities by rank, n (%) 1
HIV-positive/ AIDS 509 (13.2)‡
Coronary artery disease 6 274 (14.0)
2
Diabetes 396 (10.1)†
Diabetes 5 576 (12.5)
3
COPD/asthma 240 (6.2)†
COPD/asthma 5 162 (11.6)
4
Coronary artery disease 160 (4.1)†
Metastatic cancer 2 173 (4.9)
5
Metastatic cancer 101 (2.6)†
Congestive heart failure 2 154 (4.8)
Critical care admission
255 (6.5)
3 599 (7.7)
0.01
Unplanned critical care admission
111/255 (43.5)
1 044/3 851 (27.1)
<0.0001
ortality without critical care M admission
67/123 (53.7)
1 425/ 1 987 (71.7)
<0.0001
ortality with critical care M admission
57/255 (22.4)
506/3 599 (14.1)
0.0006
Outcomes, n (%)
*Not significantly different from EuSOS prevalence. † p<0.0001 compared with EuSOS prevalence. ‡ HIV status not reported in EuSOS.
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other comorbidities, with a negative impact on surgical outcomes; (iii) an inefficient surgical referral system; and (iv) insufficient surgical and critical care services, resulting in surgical operative delay. The data collected do not permit determination of the proportional contribution of these factors to urgent and emergency surgery, however, although the data did identify fewer surgical and critical care resources compared with Europe. It is also possible that the high proportion of urgent and emergency surgery may further contribute to increased mortality in SA patients. With a view to improving surgical outcomes, investigation of the contribution of the factors determining need for urgent/emergency surgery should be considered a public health priority.
June 2015, Vol. 105, No. 6
References 1. Weiser TG, Regenbogen SE, Thompson KD, et al. An estimation of the global volume of surgery: A modelling strategy based on available data. Lancet 2008;372(9633):139-144. [http://dx.doi. org/10.1016/S0140-6736(08)60878-8] 2. Devereaux PJ, Chan MT, Alonso-Coello P, et al. Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery. JAMA 2012;307(21):2295-2304. [http://dx.doi.org/10.1001/jama.2012.5502] 3. Pearse RM, Moreno RP, Bauer P, et al. Mortality after surgery in Europe: A 7 day cohort study. Lancet 2012;380(9847):10591065. [http://dx.doi.org/10.1016/S0140-6736(12)61148-9] 4. Grimes CE, Henry JA, Maraka J, Mkandawire NC, Cotton M. Cost-effectiveness of surgery in low- and middle-income countries: A systematic review. World J Surg 2014;38(1):252263. [http://dx.doi.org/10.1007/s00268-013-2243-y]
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Accepted 9 March 2015.
Appendix 1. Full author list
B M Biccard, PhD, Perioperative Research Group, Discipline of Anaesthesiology and Critical Care, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa; T E Madiba, PhD, Professor and Head, Department of Surgery, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa; R M Pearse, MD (Res), Professor of Intensive Care Medicine, Queen Mary University of London, Royal London Hospital, London, UK; P Alexandris, FCA (SA), Head of Department, Department of Anaesthetics, Livingstone Hospital, Port Elizabeth, South Africa; D R Bhagwandass, MMed (Anaesthesiology), Head of Department, Department of Anaesthesiology, School of Medicine, Faculty of Health Sciences, University of Limpopo (Medunsa campus), Pretoria, South Africa; K D Boffard, FRCS, Professor and Head, Department of Surgery, Faculty of Health Sciences, University of the Witwatersrand and Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa; G A Buga, PhD, Head of Department, Department of Obstetrics and Gynaecology, Faculty of Health Sciences, Walter Sisulu University and Nelson Mandela Academic Hospital, Mthatha, Eastern Cape, South Africa; E Cloete, FCA (SA), Department of Anaesthesia, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, South Africa; A Coetzee, DSc, Head of Department, Department of Anaesthesiology and Critical Care, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa; L Cronje, FCA (SA), Discipline of Anaesthesiology and Critical Care, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa; A Dhaffala, FCS, Head of Department, Department of Surgery, Faculty of Health Sciences, Walter Sisulu University, Mthatha, Eastern Cape, South Africa; B J Diedericks, MMed (Anes), Head of Department, Department of Anaesthesiology, Faculty of
473
Health Sciences, University of the Free State, Bloemfontein, South Africa; R S du Toit, MMed (Surg), Head of Department, Department of Surgery, Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa; T M Esterhuizen, MSc (Epidemiology), Biostatistician, Stellenbosch University, Tygerberg, Cape Town, South Africa; C Fourie, MMed (Anaes), Head of Department, Tygerberg Surgical ICU, Stellenbosch University, Tygerberg, Cape Town, South Africa; A Goolam Mahomed, FCP (SA), Head of Critical Care, School of Medicine, Faculty of Health Sciences, University of Limpopo (Medunsa campus), Pretoria, South Africa; P D Gopalan, FCA (SA), Head of Department, Discipline of Anaesthesiology and Critical Care, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa; F Guidozzi, FCOG, Head of Department, Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand and Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa; R W Hewson, FFICM, Barts Health NHS Trust, Adult Critical Care Unit, Royal London Hospital, Whitechapel Road, London, UK; A Hoeft, PhD, Professor and Chairman, Department of Anes thesiology and Intensive Care Medicine, University Hospital of Bonn, Germany; I Joubert, FCA (SA), Head of Department, Department of Critical Care, Faculty of Health Sciences, University of Cape Town, South Africa; D Kahn, ChM, Head of Department, Department of Surgery, Faculty of Health Sciences, University of Cape Town, South Africa; M Klipin, FCS (SA), Senior Specialist, Department of Surgery, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; H-L Kluyts, MMed (Anaes), Department of Anaesthesiology, School of Medicine, Faculty of Health Sciences, University of Pretoria, South Africa; M Z Koto, FCS (SA), Head of Department, Department of Surgery, School of Medicine, Faculty of Health Sciences, University of Limpopo (Medunsa campus), Pretoria, South Africa; B G Lindeque, MMed (O&G), Head of Department, Department of Obstetrics and Gynaecology, School of Medicine, Faculty of Health Sciences, University of Pretoria, South Africa; A C Lundgren, PhD, Head of Department, Department of Anaesthesiology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; R Machekano, PhD, Head of Department, Biostatistics Unit, Department of Interdisciplinary Health Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa; L R Mathivha, DBS (BM), Intensive Care Unit, Chris Hani Baragwanath Academic Hospital and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; T R Mokoena, DPhil (Oxon), Head of Department, Department of Surgery, School of Medicine, Faculty of Health Sciences, University of Pretoria, South Africa; S Monokoane, FCOG (SA), Head of Department, Department of Obstetrics and Gynaecology, School of Medicine, Faculty of Health Sciences, University of Limpopo (Medunsa campus), Pretoria, South Africa; R M R Moreno, PhD, UCINC, Hospital de São José, Centro Hospitalar de Lisboa Central, Lisbon, Portugal; D F Morrell, FCA (SA), Head of Department, Department of Anaesthesiology, Frere Hospital, East London, Eastern Cape, South Africa; B Mrara, FCA (SA), Head of Department, Department of Anaesthesiology, Faculty of Health Sciences, Walter Sisulu University and Nelson Mandela Academic Hospital, Mthatha, South Africa; M Ntlhe, FCS (SA), Senior Lecturer and Senior Specialist, Department of Surgery, School of Medicine, Faculty of Health Sciences, University of Pretoria and Steve Biko Academic Hospital, South Africa; E E Oosthuizen, MMed (Anaes), Head of Department, Department of Anaesthesiology, Charlotte Maxeke Johanesburg Academic Hospital, Johannesburg, South Africa;
June 2015, Vol. 105, No. 6
RESEARCH
S S Pillay, LLM RCP&S (Irel), Head of Department, Department of Surgery, School of Medicine, Faculty of Health Sciences, University of Limpopo (Polokwane campus), Polokwane, South Africa; J P Pretorius, FCS (SA), Head Clinical Unit, Department of Critical Care, School of Medicine, Faculty of Health Sciences, University of Pretoria and Clinical Unit Critical Care, Department of Surgery, Steve Biko Academic Hospital, Pretoria, South Africa; A Rantloane, MMed, Head of Department, Department of Anaesthesiology, School of Medicine, Faculty of Health Sciences, University of Pretoria, South Africa; A Rhodes, MD (Res), Divisional Chair, Children’s, Women’s, Diagnostics, Therapeutics & Critical Care, Consultant in Intensive Care Medicine and Anaesthesia, St George’s Healthcare NHS Trust, London, UK; G A Richards, PhD, Head of Department, Department of Critical Care, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; R N Rodseth, PhD, Perioperative Research Group, Discipline of Anaesthesiology and Critical Care, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa, and Grey’s Hospital, Pietermaritzburg, South Africa; M Sebitloane, FCOG, Chief Specialist, Department of Obstetrics and Gynaecology, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa; M Smith, FCS (SA), Head of Department, Department of Surgery, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; S Spijkerman, FCA (SA), Department of Anaesthesiology, School of Medicine, Faculty of Health Sciences, University of Pretoria, South Africa; M G L Spruyt, MMed (Chir), Head of Department, Department of Critical Care, Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa; J Swanevelder, FRCA (Hon), Head of Department, Department of Anaesthesiology, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, South Africa; H van der Merwe, FCOG (SA), Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, Cape Town, South Africa; B L Warren, FRCS (Edin), Professor and Head, Division of Surgery/Executive Head, Department of Surgical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch, University, Tygerberg, Cape Town, South Africa; P H Wessels, MD, Head of Department, Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa.
Appendix 2. Members of the SASOS group
SASOS Writing Committee. B M Biccard, T E Madiba, R M Pearse, P Alexandris, D R Bhagwandass, K D Boffard, G A Buga, E Cloete, A Coetzee, L Cronje, A Daffala, B J Diedericks, R S du Toit, T M Esterhuizen, C Fourie, A Goolam Mohamed, P D Gopalan, F Guidozzi, R W Hewson, A Hoeft, I Joubert, D Kahn, M Klipin, H-L Kluyts, M Z Koto, B G Lindeque, A C Lundgren, R Machekano, L R Mathivha, T R Mokoena, S Monokoane, R M R Moreno, D F Morrell, B Mrara, M Ntlhe, E E Oosthuizen, S S Pillay, J P Pretorius, A Rantloane, A Rhodes, G A Richards, R N Rodseth, M Sebitloane, M Smith, S Spijkerman, M G L Spruyt, J Swanevelder, H van der Merwe, B L Warren, P H Wessels, on behalf of the SASOS investigators. SASOS Steering Committee. B M Biccard, T E Madiba, R M Pearse, P Alexandris, D R Bhagwandass, K D Boffard, G A Buga, A Coetzee, A Daffala, B J Diedericks, R S du Toit, T M Esterhuizen, C Fourie, A Goolam Mohamed, P D Gopalan, F Guidozzi, R W Hewson, A Hoeft, I Joubert, D Kahn, H-L Kluyts, M Z Koto, B G Lindeque, A C Lundgren, R Machekano, L R Mathivha, T R Mokoena,
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S Monokoane, R M R Moreno, D F Morrell, B Mrara, M Ntlhe, E E Oosthuizen, J P Pretorius, A Rantloane, A Rhodes, G A Richards, R N Rodseth, M Sebitloane, M Smith, S Spijkerman, M G L Spruyt, J Swanevelder, H van der Merwe, B L Warren, P H Wessels, on behalf of the SASOS investigators.
Appendix 3. SASOS investigators and SASOS hospital sites
Eastern Cape Province. Cecilia Makiwane Hospital: K A Bhat*, B Dokolwana; Frere Hospital: M Coltman*, G Westcott; Livingstone Hospital: L Friedman, D Schmidt*, S Venter; Nelson Mandela Academic Hospital: A Dhaffala, B Mrara*, B Thomas, A Usenbo; Port Elizabeth Provincial Hospital: P Alexandris*, T Serdyn. Free State Province. Dihlabeng Regional Hospital: W J Selfridge, A J Stals*, W van Zyl, J Vermaak; National Hospital, Pelonomi Regional Hospital and Universitas Academic Hospital: W Barret, M Bester, J de Beer, J Geldenhuys, H Gouws, J H Potgieter*, M Strydom, E Turton. Gauteng Province. Charlotte Maxeke Johannesburg Academic Hospital: M Klipin, I Mare, V Morford*, O Smith; Chris Hani Baragwanath Academic Hospital: Y Adam, W Alhazel, K Antwi, A Atiya, M Ayuk, J Baladakis, S Baloyi, S Barka, N Biyase, N Braam, A Buitenweg, H Burcan, A Cohen, S Cuthbert, Z Dadabhay, S Davies, I du Preez, S Dulabh, W Edridge, S French, M Gayaparsad, J HamuySosa, N Hendricks, T Hlongwane, R Husein, N Hutton, T Jackson, E Jacobs, J Jocum, H Khan, N Khan, A Kiss, V Kumalo, F Lambat, A Lekha, T Leonard, D Leshaba, D Liakos, M Lindy, A C Lundgren, L T Lushiku, K Madiba, N Madima, S Maswime, R Mathiva, J J Mahlangu, M Maisto, P Makwanya, S Maswime, L Matsane, C Mitchell, B Monzon, D Moodley, J Moutlana, G Mukucha, N Murugan, J Nana, N Ndlazi, D Nel*, G Nethathe, M Nxumalo, Y Nyathela, S Nyimbana, S Omar, J Omoshoro-Jones, A Oosthuizen, E Patel, D Prem, R Pretorius, C Quan, T Ranyaka, K Rathinasamy, C Redelinghuys, N Rikhotso, C Sanders, C Segal, R Setzen, R Sheikh, Z Soni, J Steynberg, M Stubbs, O Tinubu, S Toich, S Tshukutsoane, J Vally, A van der Walt, N van der Walt, E van Greunen, D van Niekerk, L Variawa, S Veeren, C von Creytz, J Wagner, J Yogeswaram; Dr George Mukhari Hospital: D R Bhagwandass, S L L K Dlamini, A Fourie, A Goolam Mahomed, J Joseph, N Kumar, T C Maganyane, M Z Koto*, S R Motilall; Helen Joseph Hospital: G Cavedon*, K Fisher, H Jahrani, R Maja, J Malumalu, E Semenya, N Zondi; Kalafong Hospital: A Alberts, F Botha, J de Bruin, S Carrim, T Chagwiza, S East, P J H L Fourie, A Joubert, H Kluyts*, J Khosa, T Luvhengo, H Maakamedi, R Maharaj, S Motsitsi, J P Mulder, S Naidoo, H Schutte, A Vlok, M Voigt; Rahima Moosa Mother and Child Hospital: S Chetty*, M de Jager; Steve Biko Academic Hospital: Z Abdool, M Aphane, H J C du Plessis, P R Jujuju, E Moshokoa, M Ngcelwane, L M Ntlhe*, J P Pretorius, S Spijkerman, M Tshifilaro. KwaZulu-Natal Province. Addington Hospital: M M F Ansermeah, A Dunpath, J Fabian, M Khan, M Maritz, M Naidoo, S Rambarran, P Reddy, U Singh*; Edendale Hospital: N Allorto, D Bishop*, P M Builu, C Cairns, A Dasrath, J de Wet, M den Hoedt, B Grey, M Hayes, B Kusel, N Shangase, R Wise; Grey’s Hospital: S Cacala, Z Farina, V Govindasamy*, C-H Kruse, C Lee, L Marais, T D Naidoo, C Rajah, R Rodseth, L Ryan, R von Rhaden; King Dinuzulu Hospital: G Alexander, N Brouckaert, B Freeman*, S Goga; King Edward VII Hospital: R Chetty, S Chirkut, L Cronje*, K de Vasconcellos, N Z Dube, N S Gama, G Green, R Green Thompson,
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S M Kinoo, P Kistnasami, K Maharaj, M S Moodley, S Mothae, R Naidoo, A Noorbhai, V Raghubar, J Reddy, A Singh, D Skinner, M Smith, B Singh; Inkosi Albert Luthuli Central Hospital: S Adam, C Alphonsus, Y Ameer, F Anderson, S Basanth, S Bechan, C Bhula, B M Biccard*, T Biyase, J Bruce, I Buccimazza, J Cardosa, C Y Chen, B Daya, L Drummond, A Elabib, E H Abdel Goad, I E Goga, R Goga, T C Hardcastle, R Harrichandparsad, R E Hodgson, J Jordaan, N Kalafatis, C Kampik, A T Landers, E Loots, R Madansein, A Madaree, T E Madiba, V T Manzini, M Mbuyisa, R Moodley, M Msomi, D J J Muckart, I Mukama, D Naidoo, R Naidoo, T K Naidu, S Ntloko, E Padayachee, L Padayachee, M Phaff, B Pillay, D Pillay, L Pillay, A Ramnarain, S R Ramphal, P Ryan, A Saloojee, M Sebitloane, N Sigcu, J Taylor, A Torborg, L Visser; Ladysmith Hospital: I Asmal, M Gasa, G Madombwe*, S Mohanadasan; Lower Umfolozi District War Memorial Hospital: Y Bwambale*, N Mayat, L Mlambo-Williams; Madadeni and Newcastle hospitals: S Cheddie, A Elghobasy, R Hurley*, M Kopieniak, N M Naidoo; Mahatma Gandhi Hospital: M Ahmed, N Amod, M B Greenwood, B Hira, D Kesene, K Laubscher, D Naidoo, N A Mahomedy, S Moosa, V Moonsamy, S Reddy, D Rungan*, A S Sader, A Thotharam; Ngwelezane Hospital: R Misra, M Naidoo, Y Selibean, S Sewpersad*, S Sham, J Wessels; Northdale Hospital: K A Adu, J T Liphaphang, D Maiwaid*, M Marais, T Mniki; Port Shepstone Hospital: C Africander, T Bejia, S Blakemore*, M Botes, B Bunwarie, C B Hernandez, M A A Jeeraz, D Legutko, A Lopez, J de Meyer, T Muzenda, N Naidoo*, M Patel, H Pentela, M Junge, N Mansoor, L Rademan, P Scislowski, I Seedat, B van den Berg, D van der Merwe, S van Wyk; Prince Mshiyeni Hospital: K Govender*, D Naicker, R Ramjee, M Saley; R K Khan Hospital: A Ganesh, A Gounden, C Houston, S Mould, K Naidoo, A Nansook, N Rorke*, S Tarr; St Aidan’s Hospital: T Ramsamy; Stanger Hospital: W Kuhn, R Matos-Puig*, Z Moolla*. Limpopo Province. Pietersburg Provincial Hospital: M A Baloyi, L Bashiya, A Bogoslovskiy, M I Diale, N Escober, M E Gonzalez, D Horzstynski, P K Legodi, M E Maboya, R K Maila, A Z Machowski,
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M V Mashile, O R Masia, J N Masipa, M S L Masotja, R Mavhungu, M S Mokoena, T Mukwevho, S Z Mzezewa, E V Neluheni, D S Nesengani, S Omoding, L O Orjiako, N Perez, S S Pillay*, M Rambau, R Ramos, H Raura, B Ryabchiy, T O Sadiki, M D Seshibe, O S Taran, E N Thwala, B Woldu. Mpumalanga Province. Rob Ferreira Hospital: C Chikwiri, C A Cumbi, M Dalton, N P Godi, S B Ibirogba, P R Jujuju*, N R Mahlalela, F A Steyn, A J Troskie, J Vosloo. North West Province. Job Shimankana Tabane Hospital: T D Kibibi, A J M Lubamba, S J Moumakoe*, K Pege, W Seboni. Northern Cape Province. Kimberley Hospital Complex: P Ander son, A Conradie, M de Swardt*, M de Villiers, J Eikman, R Liebenberg, J Mouton, A Paton, L van der Merwe, C Wilscott-Davids. Western Cape Province. Eerste River Hospital: H Maharaj*, C Strauss; George Provincial Hospital: D Tait, M Jordaan*; Groote Schuur Hospital: K Bergh, M E Casey, E Cloete*, R Dyer, S Jeffrey, D Khan, W Makhambeni, D C Nolte, G Picken, J Swanevelder, D Visu; Helderberg and Karl Bremer hospitals: M Jaworska*; Khayelitsha District Hospital: H Lalkhen, H Maharaj*, S Serfontein; Mitchells Plain Hospital: T Biesman-Simons, S Carolissen, S Erasmus, J Holm, L Hoole, J Roos*, R Sauls, I Slabber, J van Schoor; Paarl Hospital: G Davies*, V Koller; Somerset Hospital: A Reed*, H Steinhaus; Tygerberg Hospital: I Conradie*, R Dannatt, M du Plessis, L du Preez, K du Toit, C Fourie, C Gildenhuys, A Gretschel, Y Loots, P Marwick, Y Ngcwama, R Rautenbach, P Scheepers, N Terblanche, F H van der Merwe, R van Rensburg, A Vermeulen, S Vlok, S Watcham; Victoria Hospital: N Fuller*; Worcester Hospital: W Christian, R Duvenage, T Franken, G Gobetz, W Hansen, T Kambarami*, M Kok, J Janse van Vuuren. *Lead hospital investigator.
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The impact of acute preoperative beta-blockade on perioperative cardiac morbidity and all-cause mortality in hypertensive South African vascular surgery patients Y Moodley, MMedSci; B M Biccard, MB ChB, FCA (SA), FFARCSI, MMedSci, PhD Perioperative Research Group, Department of Anaesthetics, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa Corresponding author: Y Moodley (moodleyyo@ukzn.ac.za)
Background. Acute β-blockade has been associated with poor perioperative outcomes in non-cardiac surgery patients, probably as a result of β-blocker-induced haemodynamic instability during the perioperative period, which has been shown to be more severe in hypertensive patients. Objective. To determine the impact of acute preoperative β-blockade on the incidence of perioperative cardiovascular morbidity and allcause mortality in hypertensive South African (SA) patients who underwent vascular surgery at a tertiary hospital. Methods. We conducted two separate case-control analyses to determine the impact of acute preoperative β-blockade on the incidence of major adverse cardiovascular events (MACEs, a composite outcome of a perioperative troponin-I leak or all-cause mortality) and perioperative troponin-I leak alone. Case and control groups were compared using χ2, Fisher’s exact, McNemar’s or Student’s t-tests, where applicable. Binary logistic regression was used to determine whether acute preoperative β-blocker use was an independent predictor of perioperative MACEs/troponin-I leak in hypertensive SA vascular surgery patients. Results. We found acute preoperative β-blockade to be an independent predictor of perioperative MACEs (odds ratio (OR) 3.496; 95% confidence interval (CI) 1.948 - 6.273; p<0.001) and troponin-I leak (OR 5.962; 95% CI 3.085 - 11.52; p<0.001) in hypertensive SA vascular surgery patients. Conclusions. Our findings suggest that acute preoperative β-blockade is associated with an increased risk of perioperative cardiac morbidity and all-cause mortality in hypertensive SA vascular surgery patients. S Afr Med J 2015;105(6):476-479. DOI:10.7196/SAMJ.8856
Beta-blockers are prescribed as fourth-line treatment options for hypertension in South African (SA) [1,2] patients. Withdrawal of chronic β-blockade during the perioperative period is associated with [3] poor outcomes in non-cardiac surgery patients. However, acute initiation of β-blockade during the perioperative period has also been shown to be associated with a higher risk of [4,5] adverse outcomes following non-cardiac surgery, probably as a consequence of perioperative haemodynamic instability modulated [6] by acute β-blockade. A large percentage of SA vascular patients have [7] mean blood pressures above the therapeutic target. Acknowledging that poorly controlled hypertension is highly prevalent in the SA vascular patient population, it is possible that uncontrolled hypertension could further aggravate haemodynamic instability caused by acute β-blockade, resulting in high levels of perioperative cardiac morbidity and mortality.
Objective
To determine the impact of acute preoperative β-blockade on the incidence of perioperative cardiovascular morbidity and all-cause mortality in hypertensive SA patients who underwent vascular surgery at a tertiary hospital.
Methods
Study design, setting, and patients
This study consisted of two separate case-control analyses, and was a substudy of the South African Vascular Surgical-Cardiac Risk Index (SAVS[8] CRI) study. Briefly, the SAVS-CRI study was a prospective cohort study
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conducted at Inkosi Albert Luthuli Central Hospital in Durban, SA, which sought to determine risk factors for perioperative major adverse cardiovascular events (MACEs) in vascular surgery patients. The study was approved by the University of KwaZulu-Natal Biomedical Research Ethics Committee (Protocol BF068/07, BCA117/010). A registry of consenting adult patients who underwent elective vascular surgery at the hospital between February 2008 and March 2011 was created to prospectively collect data related to demographic variables, medication use, and established risk factors for the primary outcome of this study, perioperative MACEs in vascular surgery patients receiving acute preoperative β-blockade. We did not exclude patients with respiratory, endocrine or neurological disorders from the registry, except when they were unable to provide appropriate written informed consent for inclusion in the registry. A MACE was defined as a composite of allcause mortality within 30 days of surgery or a perioperative troponin-I leak of ≥0.1 ng/ml that occurred within 3 days after a patient’s surgery. We defined patients receiving acute preoperative β-blockade as those who had a β-blocker prescribed or administered during the same hospital admission for surgery. The definitions of established risk factors [8] for adverse perioperative outcomes used in the SAVS-CRI study and [9] in this study were adopted from the study of Lee et al. We filtered the SAVS-CRI cohort for vascular surgery patients with a history of hypertension (patients diagnosed with hypertension by a doctor, or patients taking antihypertensive medications).
Matching of cases and controls
Propensity scores for all hypertensive patients were calculated following matching according to demographic factors (age, gender), clinical
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788 adult vascular surgery partients in the SAVS-CRI cohort Perioperative MACEs casecontrol analysis
Perioperative troponin-I leak case-control analysis 540 hypertensive patients
103 patients with perioperative MACEs
89 patients with perioperative troponin-I leak
99 patients with perioperative MACEs (4 patients excluded: missing data) matched with 99 patients without perioperative MACEs
86 patients with perioperative troponin-I leak (3 patients excluded: missing data) matched with 86 patients without perioperative troponin-I leak
Fig. 1. Study profiles of the perioperative MACEs and perioperative troponin-I leak case-control analyses.
factors (ischaemic heart disease, diabetes, cerebrovascular disease, renal impairment and congestive heart failure), and antihypertensive medication use (angiotensin-converting enzyme inhibitors and calcium channel blockers, but not β-blockers). For the perioperative MACEs case-control analysis, cases were defined as patients who suffered perioperative MACEs, while controls were defined as patients who did not suffer perioperative MACEs. Patients were matched in a 1:1 case-to-control ratio based on similar propensity scores, resulting in a total of 99 matched pairs that were included in the analysis for the MACEs case-control analysis. We also conducted a case-control analysis to determine the impact of acute
preoperative β-blockade on the incidence of perioperative troponin-I leak alone in hypertensive SA vascular surgery patients. Patients were matched using a methodology similar to that described for the MACEs case-control analysis, resulting in a total of 86 matched pairs that were included in the analysis for the perioperative troponin-I leak case-control analysis.
Statistical analysis
Categorical data were analysed using χ2, Fisher’s exact or McNemar’s tests, where appropriate. Student’s t-tests were used to analyse continuous data. A binary logistic regression model was used to determine whether acute preoperative β-blockade
was a predictor of perioperative MACEs or perioperative troponin-I leak. Results for the categorical data analysis are presented as frequencies and percentages, while results for the binary logistic regression analyses are presented as odds ratios (ORs) with 95% confidence intervals (CIs). Any p-value <0.05 was considered to be statistically significant. All statistical analyses, including the derivation of the propensity scores for each patient, were performed using the Statistical Package for the Social Sciences (SPSS), version 21 (SPSS Inc., USA).
Results
The study profiles for both the perioperative MACEs and the perioperative troponin-I leak case-control analyses are illustrated in Fig. 1. A total of 540/788 patients from the SAVS-CRI cohort (68.5%) were hypertensive and were screened for inclusion in the matching process. There were 103 perioperative MACEs and 89 perioperative troponin-I leaks in these 540 patients. Four patients with perioperative MACEs and 3 with perioperative troponin-I leak were excluded owing to missing comorbidity data, namely preoperative serum creatinine measurements, which were required to match cases and controls based on the criterion for renal impairment of serum creatinine [9] >177 μmol/l as defined by Lee et al. The final study population for the perioperative MACEs case-control analysis therefore consisted of 99 matched pairs of cases and controls (n=198). A total of 31/99 patients (31.4%) had died within 30 days of surgery,
Table 1. Clinical characteristics of cases and controls in the perioperative MACEs case-control analysis Clinical characteristic
All patients (N=198)
Patients with perioperative MACEs (cases, N=99)
Patients without perioperative MACEs (controls, N=99)
p-value*
Male gender, n (%)
103 (52.0)
53 (53.5)
50 (50.5)
0.670
Age (years), mean (SD)
64.4 (11.4)
64.6 (12.3)
64.2 (10.3)
0.793
Ischaemic heart disease, n (%)
119 (60.1)
57 (57.6)
62 (62.6)
0.468
Diabetes, n (%)
134 (67.7)
64 (64.6)
70 (70.7)
0.362
Congestive heart failure, n (%)
21 (10.6)
10 (10.1)
11 (11.1)
0.817
Renal impairment, n (%)
8 (4.0)
4 (4.0)
4 (4.0)
1.000
History of cerebrovascular accident, n (%)
42 (21.2)
21 (21.2)
21 (21.2)
1.000
High-risk surgical procedures, n (%)
28 (14.1)
15 (15.2)
13 (13.1)
0.683
Acute preoperative aspirin use, n (%)
190 (96.0)
94 (94.9)
96 (97.0)
0.721
Acute preoperative calcium channel blocker use, n (%)
69 (34.8)
37 (37.4)
32 (32.3)
0.456
Acute preoperative angiotensinconverting enzyme inhibitor use, n (%)
139 (70.2)
70 (70.7)
69 (69.7)
0.877
Acute preoperative β-blocker use, n (%)
100 (50.5)
65 (65.7)
35 (35.4)
<0.001
SD = standard deviation. p<0.05 was considered a statistically significant result.
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with perioperative troponin leaks noted in 15 of these cases (48.4%). The final study population for the perioperative troponin-I leak case-control analysis consisted of 86 matched pairs of cases and controls (n=172). The clinical characteristics of the case and control groups in the perioperative MACEs case-control analysis are shown in Table 1. With the exception of acute preoperative β-blocker use (p<0.001), no statistically significant results were noted on χ2 testing between any other clinical characteristics in the case and control groups, indicating appropriate matching of the individual cases and corresponding controls. The results of McNemar’s test also showed that the association between acute preoperative β-blocker use and
perioperative MACEs was statistically significant in this study (p<0.001). When entered into a logistic regression equation, acute preoperative β-blocker use was associated with an almost 3.5-fold increased risk of developing perioperative MACEs following vascular surgery in hypertensive SA patients (OR 3.496; 95% CI 1.948 - 6.273; p<0.001). Table 2 shows the clinical characteristics of cases and controls in the perioperative troponin-I leak case-control analysis. As with the perioperative MACEs casecontrol analysis, cases and controls in the perioperative troponin-I leak case-control analysis appeared to be efficiently matched with regard to clinical comorbidities, procedural risk, and calcium channel
blocker and angiotensin-converting enzyme inhibitor use. A statistically significant association between preoperative acute β-blockade and perioperative troponin-I leak was observed following χ2 testing (p<0.001). When case-control pairs were analysed via McNemar’s test, an association between acute preoperative β-blockade and perioperative troponin-I leak was observed (p<0.001). When entered into a logistic regression equation, acute preoperative β-blocker use was associated with an increased risk of developing perioperative troponin-I leak following vascular surgery in hypertensive SA patients (OR 5.962; 95% CI 3.085 - 11.52; p<0.001). A description of acute preoperative β-blocker use for both case-control analyses is presented in Table 3.
Table 2. Clinical characteristics of cases and controls in the perioperative troponin-I leak case-control analysis Clinical characteristic
All patients (N=172)
Patients with perioperative troponin-I leak (cases, N=86)
Patients without perioperative troponin-I leak (controls, N=86)
p-value*
Male gender, n (%)
87 (50.6)
45 (52.3)
42 (48.8)
0.647
Age (years), mean (SD)
63.8 (11.1)
64.2 (12.2)
63.4 (9.9)
0.657
Ischaemic heart disease, n (%)
109 (63.4)
53 (61.6)
56 (65.1)
0.635
Diabetes, n (%)
121 (70.3)
58 (67.4)
63 (73.3)
0.404
Congestive heart failure, n (%)
18 (10.5)
9 (10.5)
9 (10.5)
1.000
Renal impairment, n (%)
6 (3.5)
3 (3.5)
3 (3.5)
1.000
History of cerebrovascular accident, n (%)
39 (22.7)
20 (23.3)
19 (22.1)
0.856
High-risk surgical procedures, n (%)
27 (15.7)
14 (16.3)
13 (15.1)
0.834
Acute preoperative aspirin use, n (%)
165 (95.9)
81 (94.2)
84 (97.7)
0.443
Acute preoperative calcium channel blocker use, n (%)
58 (33.7)
32 (37.2)
26 (30.2)
0.333
Acute preoperative angiotensinconverting enzyme inhibitor use, n (%)
114 (66.3)
59 (68.6)
55 (64.0)
0.519
Acute preoperative β-blocker use, n (%)
88 (51.2)
62 (72.1)
26 (30.2)
<0.001
SD = standard deviation. *p<0.05 was considered a statistically significant result.
Table 3. Description of acute preoperative β-blocker use in both case-control analyses Perioperative MACEs case-control analysis
All patients
Patients with perioperative troponin-I leak
Patients without perioperative troponin-I leak
Beta-blockers used
All patients
Patients with perioperative MACEs
Atenolol only, n (%)
80 (80.0)
53 (81.5)
27 (77.1)
71 (80.7)
49 (79.0)
22 (84.6)
Atenolol + carvedilol, n (%)
5 (5.0)
3 (4.6)
2 (5.7)
5 (5.7)
3 (4.8)
2 (7.7)
Atenolol + labetalol, n (%)
2 (2.0)
1 (1.5)
1 (2.9)
1 (1.1)
1 (1.6)
0 (0.0)
Carvedilol only, n (%)
12 (12.0)
7 (10.9)
5 (14.3)
10 (11.4)
8 (13.0)
2 (7.7)
Labetalol only, n (%)
1 (1.0)
1 (1.5)
0 (0.0)
1 (1.1)
1 (1.6)
0 (0.0)
Total, n (%)
100 (100.0)
65 (100.0)
35 (100.0)
88 (100.0)
62 (100.0)
26 (100.0)
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Patients without perioperative MACEs
Perioperative troponin-I leak case-control analysis
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Discussion
We found acute preoperative β-blockade to be an independent predictor of perioperative cardiac morbidity (as evidenced by perioperative troponin-I measurements) and all-cause mortality in hypertensive SA vascular surgery patients. We suspect that these results are related to perioperative haemodynamic instability. Hypotension is a common perioperative complication in vascular surgery patients with a history of poorly [10] controlled hypertension, with a study by Charlson et al. reporting a higher incidence of perioperative hypotension in patients who had preoperative mean arterial blood pressures ≥110 mmHg than in those with preoperative mean arterial blood pressures of <100 mmHg. In [11] another study by Charlson et al., a decrease in mean arterial blood pressure of ≥20 mmHg for ≥5 minutes was associated with an increased incidence of perioperative cardiac complications in non-cardiac surgery patients. Perioperative hypotension is therefore an important determinant of perioperative cardiac outcomes in non-cardiac surgery patients, in particular those with poorly controlled hypertension. Acute preoperative β-blockade may further aggravate the haemodynamic instability associated with a history of poorly controlled hypertension. The POISE-I study was a randomised controlled trial comparing the effect of acutely administered, extended-release β-blocker (metoprolol succinate) with that of placebo on the 30-day risk of major cardiovascular events in patients with, or at risk of, [12] atherosclerotic disease who were undergoing non-cardiac surgery. In this study, patients randomised to acute preoperative β-blockade had significantly more hypotension. Furthermore, hypotension was associated with perioperative mortality (hazard ratio (HR) 1.33; 95% CI 1.03 - 1.74; p=0.0317). An analysis of the causation of perioperative deaths in the POISE-I study suggested that hypotension [12] was partly associated with some of the mortality. [12] Although the POISE-I study did not find perioperative hypotension to be associated with perioperative myocardial infarction [13] in non-cardiac surgery patients, the POISE-II study, which was a randomised controlled study of clonidine v. placebo, found clinically important hypotension to be independently associated with perioperative myocardial infarction (HR 1.37; 95% CI 1.16 - 1.62; [13] p<0.001). It is therefore likely that our study population of hypertensive vascular surgery patients with previously documented poorly controlled hypertension may have been predisposed towards perioperative hypotension, which could have been further exacerbated by acute preoperative β-blockade, resulting in the observed increased incidence of perioperative cardiac morbidity and all-cause mortality. These findings have important implications for primary and secondary prevention of myocardial ischaemia in the perioperative period in hypertensive vascular surgery patients.
Study limitations
Our study had several limitations. We only collected data related to perioperative cardiac outcomes and all-cause mortality during this study, and we were unable to evaluate the impact of acute preoperative β-blockade on other perioperative complications that might have occurred, such as stroke and clinically important hypotension. [12] Based on results from POISE-I, it is likely that acute preoperative β-blockade may also further increase perioperative stroke risk in SA hypertensive vascular surgical patients. We did not collect data related to chronic obstructive airway disease and were therefore unable to control for this factor in either of the case-control analyses. We also did not collect data related to neurological disorders other than cerebrovascular disease. While we did not collect data related to diabetes treatment, it is likely that diabetic patients were placed on an
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insulin sliding scale preoperatively, in line with current local practice. Although we did not collect information related to the actual dosage of the drugs administered to vascular patients in our institution, atenolol is commonly prescribed at a dose of 50 mg orally per day, labetalol is titrated to effect with heart rate control when patients cannot take medications orally, and carvedilol is prescribed for heart failure and is up-titrated to the desired effect over a period of time. In addition, we were unable to access information related to patients’ cause of death once they had been discharged from hospital. Another limitation is that our patient population was drawn from a single tertiary hospital and represented a population with substantial medical comorbidity at high-risk for perioperative cardiac complications or death, requiring specialist vascular surgery. It is therefore possible that the epidemiology of acute preoperative β-blocker administration and patient comorbidities in our study population may be different from that in patients attending lower-level facilities, or even facilities in different geographical locales within SA.
Conclusions
Acute preoperative β-blocker administration was associated with an increased risk of perioperative cardiac morbidity and all-cause mortality in hypertensive SA vascular surgery patients. A cautious approach should be taken when considering initiating acute preoperative β-blockade in hypertensive surgical patients. Acknowledgements. This study was funded by a South African Medical Research Council self-initiated research grant awarded to BMB. This work forms a component of the doctoral studies of YM, who is the recipient of a doctoral scholarship awarded by the South African National Research Foundation. YM was also supported by the Columbia University Southern African Fogarty AIDS International Training and Research Program (AITRP) Implementation Science Scholarship Program funded by PEPFAR through the Fogarty International Center, National Institutes of Health (grant # D43TW000231). References 1. Parker A, Nagar B, Thomas G, Badri M, Ntusi NB. Health practitioners’ state of knowledge and challenges to effective management of hypertension at primary level. Cardiovasc J Afr 2011;22(4):186190. [http://dx.doi.org/10.5830/CVJA-2010-066] 2. Seedat YK, Rayner BL. South African hypertension guideline 2011. S Afr Med J 2012;102(1):57-83. 3. Shammash JB, Trost JC, Gold JM, Berlin JA, Golden MA, Kimmel SE. Perioperative beta-blocker withdrawal and mortality in vascular surgical patients. Am Heart J 2001;141(1):148-153. [http:// dx.doi.org/10.1067/mhj.2001.111547] 4. Wijeysundera DN, Beattie WS, Wijeysundera HC, Yun L, Austin PC, Ko DT. Duration of preoperative beta-blockade and outcomes after major elective noncardiac surgery. Can J Cardiol 2014;30(2):217223. [http://dx.doi.org/10.1016/j.cjca.2013.10.011] 5. Bouri S, Shun-Shin MJ, Cole GD, Mayet J, Francis DP. Meta-analysis of secure randomised controlled trials of beta-blockade to prevent perioperative death in non-cardiac surgery. Heart 2014;100(6):456464. [http://dx.doi.org/10.1136/heartjnl-2013-304262] 6. Devereaux PJ, Beattie WS, Choi PT, et al. How strong is the evidence for the use of perioperative beta blockers in non-cardiac surgery? Systematic review and meta-analysis of randomised controlled trials. BMJ 2005;331(7512):313-321. [http://dx.doi.org/10.1136/bmj.38503.623646.8F] 7. Brand M, Woodiwiss AJ, Michel F, et al. Chronic diseases are not being managed effectively in either high-risk or low-risk populations in South Africa. S Afr Med J 2013;103(12):938-941. [http://dx.doi. org/10.7196/samj.6018] 8. Moodley Y, Naidoo P, Biccard BM. The South African Vascular Surgical Cardiac Risk Index (SAVS-CRI): A prospective observational study. S Afr Med J 2013;103(10):746-750. [http://dx.doi. org/10.7196/samj.6967] 9. Lee TH, Marcantonio ER, Mangione CM, et al. Derivation and prospective validation of a simple index for prediction of cardiac risk of major noncardiac surgery. Circulation 1999;100(10):1043-1049. [[http://dx.doi.org/10.1161/01.CIR.100.10.1043] 10. Charlson ME, MacKenzie CR, Gold JP, Ales KL, Topkins M, Shires GT. Preoperative characteristics predicting intraoperative hypotension and hypertension among hypertensives and diabetics undergoing noncardiac surgery. Ann Surg 1990;212(1):66-81. 11. Charlson ME, MacKenzie CR, Gold JP, et al. The preoperative and intraoperative hemodynamic predictors of postoperative myocardial infarction or ischemia in patients undergoing noncardiac surgery. Ann Surg 1989;210(5):637-648. 12. Devereaux PJ, Yang H, Yusuf S, et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): A randomised controlled trial. Lancet 2008;371(9627):1839-1847. [http://dx.doi.org/10.1016/S0140-6736(08)60601-7] 13. Devereaux PJ, Sessler DI, Leslie K, et al. Clonidine in patients undergoing noncardiac surgery. N Engl J Med 2014;370(16):1504-1513. [http://dx.doi.org/10.1056/NEJMoa1401106]
Accepted 21 April 2015.
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Granulomas at initial diagnosis of Crohn’s disease signal a poor outcome G Watermeyer, MB ChB, FCP, Cert Gastroenterol, MPH; S R Thomson, ChM, FRCS Division of Gastroenterology, Department of Medicine, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa Corresponding author: G Watermeyer (gillian.watermeyer@uct.ac.za)
Background. Over time, most patients with Crohn’s disease (CD) develop strictures or fistulas, resulting in hospitalisations and surgery. Timely therapy with immunomodulators and biologicals may alter this natural history, but carries a significant risk of side-effects. Objective. To identify factors to predict poor-outcome severe CD at diagnosis, and thus patients who would benefit most from early, aggressive medical therapies. Methods. CD patients (n=101) with uncomplicated non-stricturing, non-penetrating disease at diagnosis, and with follow-up >5 years, were retrospectively analysed using a predefined definition of severe CD (SCD) over the disease course. Clinical, demographic, laboratory and histological factors at diagnosis associated with SCD and poor outcome were evaluated by univariate and multivariate analysis. Results. Overall 33.7% of the cohort developed SCD, and on multivariate Cox proportional hazard analysis the presence of granulomas on endoscopic biopsy at diagnosis was independently associated with development of SCD (hazard ratio (HR) 2.3; 95% confidence interval (CI) 1.15 - 4.64; p=0.02). Simple perianal disease was also associated with this outcome (HR 2.49; 95% CI 1.14 - 5.41; p=0.02). The presence of these variables had a specificity of 99% and a positive predictive value of 88%. Conclusion. At diagnosis, factors predictive of SCD in our referral centre were the presence of endoscopic biopsy granulomas and perianal disease. Patients with these risk factors should be considered for early, aggressive medical therapy, as benefit will probably outweigh risk. To our knowledge, this is the first study to show that endoscopic biopsy granulomas in patients with uncomplicated (non-stricturing, nonpenetrating) CD predict the subsequent development of SCD. S Afr Med J 2015;105(6):480-483. DOI:10.7196/SAMJ.9093
Crohn’s disease (CD) is a chronic disorder with variable clinical manifestations and a heterogeneous disease course. The phenotype is defined by age at diagnosis, location, and disease behaviour according to the Montreal classification[1] (Table 1). Behaviour is categorised as the uncomplicated ‘non-stricturing and non-penetrating’ (B1) phenotype, ‘stricturing’ (B2) phenotype and ‘penetrating’ (B3) phenotype. Penetrating CD is also known as fistulising CD. The behaviour of CD tends to evolve over time to be complicated by the development of strictures, fistulas or abscesses. At diagnosis 80% of patients have purely inflammatory B1 luminal disease, but by 10 years more than half will have progressed to complicated B2 and B3 phenotypes, often requiring hospitalisation.[2,3] Ultimately 80% with this progression require surgery.[4] Aggressive medical therapy with immuno modulators (IMMs) such as azathioprine or methotrexate and biologicals may alter this natural history and improve long-term outcomes, but should be introduced early in the disease course, before the development of irreversible complications.[5-7] Such strategies place patients at risk of adverse events, notably infections and malignant disease.[8,9] Populationbased studies have shown that a sizeable num
ber of CD patients will have a benign course, never require surgery and never suffer a flareup severe enough to warrant corticosteroids,[10] and to subject these individuals to drugs with potentially serious side-effects is of concern. In addition, these medications (notably biologicals) are expensive, and access is limited in resource-challenged environments such as ours in South Africa (SA). Several studies have analysed factors early in the course of CD that may predict future outcomes and identify those patients at risk of developing complicated CD and who would receive greatest benefit from early, aggressive therapy. A number of clinical variables have been associated with the subsequent development of pooroutcome CD, notably an initial need for corticosteroids, age <40 years, ileocolonic location, stricturing behaviour, weight loss >5 kg and perianal disease at diagnosis.[11,12] Several serological markers, such as antiSaccharomyces cerevisiae antibodies, have also been shown to predict disease severity, as have tissue granulomas.[13,14] More recently Siegel et al.[15] developed a model using system dynamics analysis to assess the probability of developing a CD-related complication. This model included patient and disease variables,
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Table 1. Classification of Crohn’s disease according to the Montreal classification[1] Age at diagnosis A1: ≤16 years A2: 17 - 40 years A3: >40 years Location L1: Ileal L2: Colonic L3: Ileocolonic L4: Isolated upper GIT* Behaviour B1: Non-stricturing, non-penetrating (inflammatory) B2: Stricturing B3: Penetrating P: Perianal disease modifier† GIT = gastrointestinal tract. *L4 can be added to locations L1 - L3 to indicate coexisting upper GI disease. † P can be added to any behaviour to indicate coexisting perianal disease.
serological markers and medical therapies. They demonstrated how data can be transformed into a simple graph showing
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a real-time individualised probability of disease complications. Unfortunately serological markers are not available and are not tested for in our CD subjects, limiting such an approach in our setting. Furthermore, it is unclear whether the predictive clinical variables from European populations are applicable in our local setting, given that our patients differ from those treated in the West. Notably CD is more aggressive in non-Caucasians, the incidence is higher, and common genetic CD susceptibility mutations frequently seen in the developed world are absent in our clinic population.[16,17] In addition, all these European studies included subjects who already had complicated penetrating or stricturing phenotypes at diagnosis, indicating some degree of irreversible damage to the gastrointestinal tract. Ability to evaluate predictive factors for SCD in patients with uncomplicated CD at diagnosis would be of greater value, as these are the patients in whom one may realistically hope to change the natural history of the disease. To date no study has been done in SA to analyse risk factors predicting poor-outcome CD in uncomplicated B1 disease at diagnosis. In view of the potential risk of progression to complicated CD over time, and the lack of local evidence regarding which patients are at risk, the aim of this study was to evaluate clinical and laboratory indices in subjects with uncomplicated CD, as well as endoscopic biopsy granulomas at the time of diagnosis, and the association with adverse disease outcomes.
Methods
The research protocol was approved by the Ethics Committee of the University of Cape Town. A retrospective cohort study was conducted evaluating all patients diagnosed with CD (duration >5 years) in our unit to 31 December 2011. Of 567 CD patients registered on our database, 310 were eligible for inclusion. We reviewed their clinical records. Patients were excluded if there were incomplete data at baseline (n=151), if they had not been seen within 12 months (n=10), if there was complex perianal, stricturing or penetrating CD at diagnosis (n=37), or if they had undergone surgical resection within 1 month of diagnosis (n=9). Two further subjects were excluded because their diagnosis was revised. Overall 84% of patients with data at diagnosis had B1 disease. Complex perianal disease was defined according to the American Gastroenterology Association recommendation as ‘fistulas that are high intersphincteric, high transsphincteric, extrasphincteric or suprasphincteric, have multiple external openings, are associated with a perianal abscess, fistulise to adjacent organs, are associated with the presence of an anorectal stricture or associated with the presence of active rectal disease’.[18] Severe CD (SCD) was defined (as previously described by Loly et al.[11] as the presence of any of the following over the entire disease course: ‘complex perianal disease; any colonic resection; two or more small-bowel resections; a single small-bowel resection more than 50 cm in length; or construction of a definitive stoma’. Patients were followed up from CD diagnosis until 31 December 2011, or alternatively until the development of SCD. The following data were collected at diagnosis and during follow-up: demographics, clinical and biochemical variables, histological evidence of granulomas, corticosteroid use, hospitalisations, surgeries, creation of a definitive stoma, progression from B1 to B2 or B3 phenotypes, IMMs or biological use, and the development of perianal fistulas.
Statistical analysis
All continuous variables evaluated were not normally distributed and are therefore expressed as medians and interquartile ranges (IQRs). Categorical variables were compared using the χ2 or Fisher’s exact test, as appropriate. In addition, univariate and multivariate Cox proportional
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hazard analysis was performed to identify risk factors associated with time to the development of SCD. Variables with p-values ≤0.2 were included in the multivariate model. The Kaplan-Meier method was used to estimate the cumulative probability of developing SCD as well as progression from B1 to B2 or B3 phenotypes over time.
Results
Overall, 101 subjects were eligible for inclusion in the study. The median age at diagnosis was 31 years (IQR 23 - 39), and 61.4% (62/101) were female. At diagnosis 36.6% (37/101) had isolated ileocaecal (L1) disease, 27.7% (28/101) isolated colonic (L2) disease and 35.6% (36/101) ileocolonic (L3) disease. Six patients (5.9%) also had involvement of the upper GIT, 13.9% (14/101) had evidence of simple perianal disease, 65.3% (66/101) were active cigarette smokers, 55.4% (56/101) were treated with corticosteroids for the first flare of disease, and 41.6% (42/101) had noncaseating granulomas on endoscopic biopsy at diagnosis. Overall, 33.7% of patients (34/101) developed SCD over their disease course. The median time to the development of SCD was 103 months (IQR 60 - 144). The cumulative probability of developing SCD was 11%, 21% and 30% at 1, 5 and 10 years after diagnosis, respectively. Predictors at diagnosis associated with the time to development of SCD are presented in Table 2. After multivariate analysis, only perianal disease (hazard ratio (HR) 2.49; 95% confidence interval (CI) 1.14 - 5.41; p=0.02) and granulomas (HR 2.3; 95% CI 1.15 - 4.64; p=0.02) at diagnosis were independently associated with time to the development of SCD. There were no statistically significant differences when evaluating patients with or without granulomas. There was also no difference in baseline variables in subjects with or without perianal CD. Kaplan-Meier curves for the development of SCD according to the presence or absence of these two factors are shown in Fig. 1. Sensitivity, specificity, positive predictive value and negative predictive value of a logistic regression model including these two risk factors were 21%, 99%, 88% and 71%, respectively. Of patients with B1 disease at diagnosis, 42.3% progressed to B2 or B3 phenotype over time. The cumulative probability of developing either of these complicated phenotypes was 13% at 1 year, 24% at 2 years, 33% at 5 years and 43% at 10 years. The median time to progression was 24 months (IQR 11 - 78). None of the baseline parameters assessed was significantly associated with time to B2 or B3 progression. Forty patients (39.6%) with a B1 phenotype at diagnosis ultimately required a surgical resection, while 26 (25.7%) underwent two or more surgical resections. The presence of granulomas at diagnosis was the only predictor for more than one resection during follow-up (OR 4.7; 95% CI 1.8 - 12.3; p=0.002).
Discussion
Our results are consistent with previous reports in that the majority of CD patients with uncomplicated B1 CD at diagnosis went on to a disabling disease course over time. We only included subjects with purely inflammatory B1 disease at diagnosis, as most patients who have stricturing or penetrating phenotypes or complex perianal CD would already be considered to have complicated disease and therefore to be candidates for aggressive therapy with IMMs and biologicals.[5] As such, predicting poor-outcome CD in these patients is not as valuable as in patients with uncomplicated disease, in whom the decision to start disease-modifying therapies has far more important consequences. Overall, 33.7% of our cohort developed SCD over their disease course. This is almost identical to the figure reported by Loly et al.[11] in their Liège cohort. In keeping with several other studies, perianal disease emerged as a strong predictor of poor-outcome CD.[12,19] Our analysis also revealed that endoscopic tissue biopsy granulomas at diagnosis were associated with earlier development of SCD and were
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Table 2. Risk factors at diagnosis significantly associated with time to development of SCD, analysed with the Cox proportional hazard method Risk factors at diagnosis
Severe CD (N=34, 33.7%)
Non-severe CD (N=67, 66.3%)
Unadjusted HR; 95% CI; p-value
Adjusted HR; 95% CI; p-value
Female gender, n (%)
18 (52.9)
44 (65.7)
0.64; 0.33 - 1.26; 0.20
0.59; 0.32 - 1.1; 0.1 Not included
Race, n (%) White
8 (23.5)
13 (19.4)
1; Reference; 0.89
Black
2 (5.9)
4 (6.0)
0.88; 0.13 - 5.9
Coloured
24 (70.6)
50 (74.6)
0.86; 0.32 - 2.32 9
A1, <17
4 (11.8)
47 (6.0)
1; Reference; 0.28
Not included
A2, 17 - 40
25 (73.2)
45 (67.2)
A3, >40
5 (14.7)
18 (26.9)
25 (73.5)
5 (7.5)
3.05; 1.42 - 6.56; 0.004
2.49; 1.14 - 5.41; 0.02
1; Reference; 0.52
Not included
Age (years), n (%)
Perianal disease, n (%) Location, n (%) L1
14 (41.2)
23 (34.3)
L2
7 (20.6)
21 (31.3)
L3
13 (38.2)
23 (34.3)
Extent of SB >20 cm, n (%)
18 (52.9)
43 (64.2)
1.03; 0.98 - 1.08; 0.26
Not included
Colonic segments involved (n), mean (range)
2 (0 - 3)
1 (0 - 3)
0.94; 0.8 - 1.11; 0.45
Not included
Upper GIT, n (%)
3 (8.8)
37 (4.5)
1.65; 0.5 - 5.4; 0.41
Not included
Rectal involvement, n (%)
6 (17.6)
13 (19.4)
0.96; 0.4 - 2.32; 0.93
Not included
Family history, n (%)
2 (5.9)
57 (7.5)
0.97; 0.23 - 4.04; 0.96
Not included
Current smoker*, n (%)
20 (58.8)
46 (68.7)
0.59; 0.30 - 1.18; 0.14
Not included
Appendicectomy, n (%)
3 (8.8)
2 (3.0)
1.68; 0.51 - 5.48; 0.39
Not included
>5 kg weight loss, n (%)
23 (67.6)
34 (50.7)
1.89; 0.91 - 3.86; 0.09
1.82; 0.87 - 3.8; 0.11
Steroids, n (%)
19 (55.9)
38 (56.7)
1.13; 0.57 - 2.24; 0.70
Not included
EIMs, n (%)
8 (23.5)
18 (26.9)
0.8; 0.35 - 1.72; 0.53
Not included
Granulomas, n (%)
21 (61.8)
21 (31.3)
2.33; 1.17 - 4.66; 0.02
2.3; 1.15 - 4.64; 0.02
SB = small bowel; EIMs = extraintestinal manifestations. *Patients were considered current smokers if â&#x2030;Ľ7 cigarettes per week.
0.00
0.25
0.50
0.75
1.00
Severe CD
0
100
200 Time from diagnosis (months)
No perianal CD or granulomas
300
400
Both perianal disease & granulomas
Fig. 1. Kaplan-Meier curves for the development of SCD according to the presence or absence of perianal disease and granulomas at diagnosis in patients with B1 phenotype.
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the only predictor for more than one surgical procedure during follow-up. Granulomas are considered a histological characteristic of CD. However, in reality less than 50% of patients will have them on biopsy specimens, and their pathogenesis is unknown. Several studies evaluating poor-outcome CD have included granulomas in analysis, and although results are conflicting, most favour granulomas as a predictor of aggressive CD. A 2010 meta-analysis concluded that granulomas appear to be associated with a higher number of recurrences and surgeries.[14] However, it is difficult to draw conclusions from this analysis given significant heterogeneity between studies. A study by Freeman[20] showed that the presence of granulomas was linked to a more complicated disease course, with more extensive ileocolonic and upper gastrointestinal tract involvement and more penetrating disease. In addition, Heresbach et al.[21] demonstrated that the presence of granulomas independently predicted the need
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for surgical resection. More recent publications have confirmed these findings.[22] However, many of these studies are confounded by the inclusion of granulomas found in surgical resection specimens as well as those found on endoscopic biopsies. Furthermore, analysis included the development of granulomas at any point over the disease course. Molnár et al.[23] performed a small prospective study which showed that at diagnosis granulomas on endoscopic biopsy were associated with a higher need for surgery or IMMs; these authors, however, included subjects with B2 and B3 disease at diagnosis. Patients with granulomas also had significantly higher CD activity index values at diagnosis than those without, a finding that was not adjusted for in analysis. Similarly, a paediatric study showing that endoscopic biopsy granulomas at diagnosis were associated with increased need for surgery included children with complex perianal CD.[24] To our knowledge, this study is the first to include only endoscopic tissue biopsy granulomas at the time of first diagnosis in uncomplicated B1 CD. It is unclear how granulomas may influence CD outcomes. One possible explanation is an association with autophagy genetic variants. Autophagy is a process involved in the elimination of intracellular bacteria, and this pathway appears to be altered in CD. Reduced clearance of pathogenic bacteria may drive the chronic inflammation observed in these patients. Genetic variants in autophagy genes, notably autophagy-related gene 16-like 1 (ATG16L1) and immunityrelated GTPase M (IRGM), have been associated with susceptibility to CD. A recent study from Leuven evaluated surgical specimens from 464 CD patients and found associations between granulomas and several autophagy gene variants.[22] Another possible mechanism that could explain the association of granulomas with poor-outcome CD is the observation that granulomas can cause lymphatic obstruction, which could lead to chronic tissue oedema with subsequent irreversible fibrosis.[25]
Study limitations
Our study has a number of limitations. Firstly, we excluded patients with incomplete data at diagnosis. This is a potential source of selection bias; however, it is likely that these data were missing at random and not correlated with CD severity or outcome. Another potential source of bias is that only patients with complete follow-up data were included. This could introduce selection bias, as patients lost to follow-up may have had less severe disease than those who continued to be seen in our clinic. However, the cumulative probabilities of progressing from B1 disease at diagnosis to stenosing or penetrating phenotypes is almost identical to those reported in a large population-based study from Olmsted County, Minnesota, USA.[26] Furthermore, the baseline demographics (age and gender) as well as disease location and behaviour of our study participants were very similar to those reported in a New Zealand population-based CD cohort.[19] Finally, our study is limited by the retrospective nature of the analysis; in many subjects the number and site of endoscopic biopsies, and the number of granulomas, were not recorded. Despite these limitations, our study has provided some valuable information. This is the first SA study to identify predictors of pooroutcome CD in patients with B1 disease. This will aid the decision in our setting about when to risk aggressive medical therapies early in the disease course. As emphasised by Louis et al.[27] in a recent review, there are two possible errors in managing CD: overtreating patients who will have benign disease, and undertreating those who will go on to develop poor outcomes. In our study, perianal disease and granulomas at diagnosis were very specific for the development of SCD over the disease course. Only 1% of individuals with these two predictors at diagnosis would be falsely classified as having SCD and therefore subjected to
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aggressive therapies unnecessarily. In addition, these two risk factors are routinely assessed at baseline and do not require expensive blood testing or genetic analysis.
Conclusion
Data from this retrospective study have shown that 34% of our cohort developed severe poor-outcome CD over their disease course. Our study has identified several factors at diagnosis of B1 CD that are predictive of this outcome. Notably, perianal disease and endoscopic biopsy granulomas were independently associated with time to the development of SCD. The latter is a novel finding and merits further prospective evaluation in different populations as a potential factor that accurately predicts progression from B1 disease to SCD and could therefore be used to identify patients who merit selection for aggressive medical therapies. References 1. Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: Controversies, consensus, and implications. Gut 2006;55(6):749-753. [http://dx.doi. org/10.1136/gut.2005.082909] 2. Cosnes J, Cattan S, Blain A, et al. Long-term evolution of disease behaviour of Crohn’s disease. Inflamm Bowel Dis 2002;8(4)244-250. [http://dx.doi.org/10.1097/00054725-200207000-00002] 3. Louis E, Collard A, Oger AF, et al. Behaviour of Crohn’s disease according to the Vienna classification: Changing pattern over the course of the disease. Gut 2001;49(6):777-782. [http://dx.doi.org/10.1136/gut.49.6.777] 4. Mekhjian HS, Switz DM, Watts HD, et al. National Cooperative Crohn’s Disease Study: Factors determining recurrence of Crohn’s disease after surgery. Gastroenterology 1979;77(4):907-913. 5. Dignass A, van Assche G, Lindsay JO, et al. The second European evidence-based consensus on the diagnosis and management of Crohn’s disease: Current management. J Crohns Colitis 2010;4(1):2862. [http://dx.doi.org/10.1016/j.crohns.2009.12.002 plus corrigendum http://dx.doi.org/10.1016/j. crohns.2010.07.001] 6. Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine or combination therapy for Crohn’s disease. N Engl J Med 2010;362(13):1383-1395. [http://dx.doi.org/10.1056/NEJMoa0904492] 7. D’Haens G, Baert F, van Assche G, et al. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn’s disease: An open randomised trial. Lancet 2008;371(9613):660-667. [http://dx.doi.org/10.1016/S0140-6736(08)60304-9] 8. Toruner M, Loftus EV Jr, Harmsen WS, et al. Risk factors for opportunistic infections in patients with inflammatory bowel disease. Gastroenterology 2008;134(4):929-936. [http://dx.doi.org/10.1053/j. gastro.2008.01.012] 9. Lichtenstein GR, Feagan BG, Cohen RD, et al. Serious infections and mortality in association with therapies for Crohn’s disease: TREAT registry. Clin Gastroenterol Hepatol 2006;4(7):621-630. [http:// dx.doi.org/10.1016/j.cgh.2006.03.002] 10. Munkholm P, Langholz E, Davidsen M, et al. Frequency of glucocorticoid resistance and dependency in Crohn’s disease. Gut 1994;35(3):360-362. 11. Loly C, Belaiche J, Louis E. Predictors of severe Crohn’s disease. Scand J Gastroenterol 2008;43(8):948954. [http://dx.doi.org/10.1080/00365520801957149] 12. Beaugerie L, Seksik P, Nion-Larmurier I, et al. Predictors of Crohn’s disease. Gastroenterology 2006;130(3):650-656. [http://dx.doi.org/10.1053/j.gastro.2005.12.019] 13. Mow W, Vasiliauskas E, Lin Y, et al. Association of antibody responses to microbial antigens and complications of small bowel Crohn’s disease. Gastroenterology 2004;126(2):414-424. [http://dx.doi. org/10.1053/j.gastro.2003.11.015] 14. Simillis C, Jacovides M, Reese G, et al. Meta-analysis of the role of granulomas in the recurrence of Crohn disease. Dis Colon Rectum 2010;53(2):77-185. [http://dx.doi.org/10.1007/DCR.0b013e3181b7bfb0] 15. Siegel CA, Siegel LS, Hyams JS, et al. Real-time tool to display the predicted disease course and treatment response for children with Crohn’s disease. Inflamm Bowel Dis 2011;17(1):30-38. [http:// dx.doi.org/10.1002/ibd.21386] 16. Zaahl MG, Winter T, Warnich L, et al. Analysis of the three common mutations in the CARD15 gene (R702W, G908R and 1007fs) in South African coloured patients with inflammatory bowel disease. Mol Cell Probes 2005;19(4):278-281. [http://dx.doi.org/10.1016/j.mcp.2005.03.001] 17. Basson A, Swart R, Jordaan E, et al. The association between race and Crohn’s disease phenotype in the Western Cape population of South Africa, defined by the Montreal Classification System. PLoS One 2014;9(8):e104859. [http://dx.doi.org/10.1371/journal.pone.0104859] 18. Sandborn WJ, Fazio VW, Feagan BG, et al., American Gastroenterological Association Clinical Practice Committee. AGA technical review on perianal Crohn’s disease. Gastroenterology 2003;125(5):15081530. [http://dx.doi.org/10.1016/j.gastro.2003.08.025] 19. Tarrant KM, Barclay ML, Frampton CM, et al. Perianal disease predicts changes in Crohn’s disease phenotype – results of a population-based study of inflammatory bowel disease phenotype. Am J Gastroenterol 2008;103(12):3082-3093. [http://dx.doi.org/10.1111/j.1572-0241.2008.02212.x] 20. Freeman HJ. Granuloma-positive Crohn’s disease. Can J Gastroenterol 2007;21(9):583-587. 21. Heresbach D, Alexandre JL, Branger B, et al. Frequency and significance of granulomas in a cohort of incident cases of Crohn’s disease. Gut 2005;54(2):215-222. [http://dx.doi.org/10.1136/gut.2004.041715] 22. Brinar M, Vermeire S, Cleynen I, et al. Genetic variants in autophagy-related genes and granuloma formation in a cohort of surgically treated Crohn’s disease patients. J Crohns Colitis 2012;6(1):43-50. [http://dx.doi.org/10.1016/j.crohns.2011.06.008] 23. Molnár T, Tiszlavicz L, Gyulai C, Nagy F, Lonovics J. Clinical significance of granuloma in Crohn’s disease. World J Gastroenterol 2005;11(20):3118-3121. 24. Markowitz J, Kahn E, Daum F. Prognostic significance of epithelioid granulomas found in rectosigmoid biopsies at the initial presentation of pediatric Crohn’s disease. J Pediatr Gastroenterol Nutr 1989;9(2):182-186. [http://dx.doi.org/10.1097/00005176-198908000-00009] 25. Van Kruiningen HJ, Hayes AW, Colombel JF. Granulomas obstruct lymphatics in all layers of the intestine in Crohn’s disease. APMIS 2014;122(11):1125-1129. [http://dx.doi.org/10.1111/apm.12268] 26. Thia KT, Sandborn WJ, Harmsen, et al. Risk factors associated with progression to intestinal complications of Crohn’s disease in a population-based cohort. Gastroenterology 2010;139(4):11471155. [http://dx.doi.org/10.1053/j.gastro.2010.06.070] 27. Louis E, Belaiche J, Reenaers C. Tailoring the treatment to the individual in Crohn’s disease. Ther Adv Gastroenterol 2009;2(4):239-244. [http://dx.doi.org/10.1177/1756283X09337180]
Accepted 21 April 2015.
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Waiting times for prostate cancer diagnosis in KwaZulu-Natal, South Africa K Singh,1 MB ChB; E H Abdel Goad,1 MB ChB, FCUrol, MMedSc, FEBU, FRCS (Ire); S S Ramklass,2 BPhysiother, MEd, DEd epartment of Urology, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, D University of KwaZulu-Natal, Durban, South Africa 2 College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa 1
Corresponding author: K Singh (sngkir@gmail.com)
Background. There is currently no evidence in the South African (SA) literature to suggest how long patients with clinically suspected prostate cancer (an elevated prostate-specific antigen level or abnormal findings on digital rectal examination) wait to have a prostate biopsy. Objectives. To improve the overall efficiency of the prostate biopsy service offered at St Aidan’s Regional Hospital, Durban, SA, by quantifying the burden of disease and waiting times and to identify potential delays in management outcomes, thereby helping to alleviate patient anxiety during the stressful period of investigation. Methods. We did a retrospective folder review of patients who underwent trans-rectal prostate biopsy at St Aidan’s Hospital, where the vast majority of prostate biopsies in the KwaZulu-Natal state healthcare sector are performed, from January to June 2013. The Statistical Package for Social Sciences was used for data analysis. Results. One hundred and six patients (mean age 67.6 years, 69.8% black Africans) underwent biopsy during the 6-month study period; 49.1% were found to have adenocarcinoma, and of the 80.1% of these who had a bone scan, 73.8% had skeletal metastases (p=0.1379). The median period of time from referral to biopsy was 55 days, from referral to first follow-up date (when the diagnosis is given and treatment options discussed or instituted) 100 days, and from biopsy to first follow-up date (i.e. waiting period to retrieve histological diagnosis) 36 days. Conclusion. Despite the late presentation of prostate cancer in KZN, patients are waiting an average of 3 months from initial referral for a prostate biopsy to institution of definitive management. S Afr Med J 2015;105(6):484-486. DOI:10.7196/SAMJ.9192
Prostate cancer is a very common malignancy in many countries. In the USA it accounts for almost a third (31.2%) of all cancers, ranking second only to lung cancer as the cause of death in men (11.7%). [1] There seems to be a paucity of evidence regarding the epidemiology of prostate cancer in sub-Saharan Africa.[2-3] It is, however, known that men of African descent appear to suffer disproportionately more from prostate cancer compared with men of other races or ethnicities,[4] and present with more advanced disease.[5-8] To date most, if not all, of the epidemiological studies on prostate cancer in South Africa (SA) have been undertaken by Heyns and colleagues in the Western Cape Province,[5,9-13] and their findings have influenced national guidelines and policy. However, it remains to be established whether these findings are consistent among the various provinces of SA, in part because of different racial composition and socioeconomic status of populations. With the imminent roll-out of National Health Insurance (NHI) in SA, there is a need to quantify the burden of prostate cancer on the health service. In a resource-deprived setting such as KwaZulu-Natal Province (KZN), human resources and infrastructure need to be allocated appropriately to enhance the quality of care that patients receive.[14] There is currently no literature in SA regarding how long patients with suspected prostate cancer wait to have a prostate biopsy in the public healthcare sector, and how long they wait to initiate treatment.
Objectives
To form a framework to improve the overall efficiency of the prostate biopsy service at St Aidan’s Hospital, Durban, which serves as a
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specialist urology referral centre. We described the patient profile, referral pattern and pathological burden of disease, calculated the waiting period in days from peripheral hospital referral to biopsy date, and attempted to identify high-risk groups in which referral should be expedited and to identify potential delays in management.
Methods
A retrospective folder review of patients who had undergone transrectal prostate biopsy for clinically suspected prostate cancer was undertaken at the Urology Cinic at St Aidan’s Hospital from January 2013 to June 2013. Patients were referred to the service directly from peripheral health facilities and local hospitals in the eThekwini district, KZN. All patients had sextant trans-rectal ultrasound-guided (TRUS) biopsies for the first time, and only those with confirmed histological findings were included. The study was three-tiered and aimed at defining the scope of the burden of disease on the service, calculating the waiting times and describing the referral patterns. Patients self-assigned their race as black African, white, Indian or coloured (of mixed ancestry). Time intervals were calculated from dates obtained from referral notes. Three different time intervals were calculated: (i) from referral to biopsy, i.e. the number of days a patient waited to receive a biopsy after being referred to the service; (ii) from referral to first followup, i.e. the number of days a patient waited to receive a histological diagnosis, and for treatment options to be discussed or instituted; and (iii) from biopsy date to first follow-up date, i.e. waiting period to retrieve a histological diagnosis, or histology processing time.
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Because of incomplete and manual record keeping, we were unable to do accurate clinical staging according to the 2002 TNM classification. However, patients were risk-stratified according to the D’Amico risk stratification,[15] using prostate-specific antigen (PSA) in most instances. Haematogenous metastases were detected by skeletal scintigraphy (bone scan). Indications for prostate biopsy included a serum PSA level >4 ng/mL or suspicious findings on digital rectal examination (DRE).
Adenocarcinoma 6.6% n=7
Benign prostatic hyperplasia Prostatitis Inadequate specimen
24.5% n=26
49.1% n=52
19.8% n=21
Statistical analysis
Data were captured using Microsoft Excel and analysed using the Statistical Package for Social Sciences (SPSS version 21) in consultation with a biostatistician. Comparison of means was performed using Student’s t-test for parametric data and the Mann-Whitney and KruskalWallis tests for non-parametric data. Fisher’s exact test was used for contingency table analysis. A two-tailed p-value of <0.05 was accepted as statistically significant.
Fig. 1. Categorisation of histological outcomes.
9.6% n=5
Black African
7.7% n=4
White Indian Coloured
7.7% n=4
Ethical approval
Ethical approval for the study was granted by the University of KwaZulu-Natal Biomedical Research Ethics Committee and the KwaZulu-Natal Provincial Health and Research Ethics Committee.
75.0% n=39
Results
485
Fig. 2. Racial distribution of prostate cancer.
PSA (ng/mL)
One hundred and six patients (mean age 67.6 years (standard deviation 7.51)) underwent TRUS biopsy. Of these patients, 69.8% (n=74) were classified as black, 4.7% (n=5) as white, 13.2% (n=14) as Indian and 12.3% (n=13) as coloured. Almost half of the patients (49.1%, n=52) were found to have adenocarcinoma. Other findings included benign prostatic hyperplasia, prostatitis, and inadequate specimen for analysis. The distribution of histological findings is illustrated in Fig. 1. The majority of malignancies (75.0%, n=39) were found in black patients (Fig. 2). According to the D’Amico risk stratification, 68.9% (n=51) of black patients were classified as high risk v. 4.7% of whites (n=5), 13.2% of Indians (n=14) and 12.3% of coloureds (n=13), which was statistically significant (p<0.001). The median PSA level (Fig. 3) of black African patients with prostate cancer was 42.2 ng/mL v. 12.8 ng/mL for whites, 10.3 ng/mL for Indians and 14.2 ng/mL for coloureds, which was also statistically significant (p<0.001). The median PSA level of patients with confirmed carcinoma was 133.5 ng/mL, as opposed to 16.0 ng/mL for those without cancer (p<0.01). A relationship was observed between initial PSA level and Gleason score (p=0.01). We were unable to stage patients according to the TNM classification, as in 36.8% of folders the DRE findings were not adequately documented. Of the 52 patients with histologically confirmed adenocarcinoma, 80.1% (n=42) received a bone scan; in 73.8% (n=31) skeletal scintigraphy confirmed metastases, 8 (18.6%) had no metastases, and 4 (9.3%) had equivocal findings (p=0.1379). With regard to treatment modalities, 92.5% of patients (n=98) received some form of medication; only 8.5% (n=9) underwent surgical intervention, while 4.7% (n=5) received external-beam radiation. Medication included alpha-blockers (n=32), antibiotics (n=4), androgen-deprivation therapy (ADT) (n=47) and combination regimens (n=62). Of the patients with confirmed adenocarcinoma, 90.4% received ADT. The majority of referrals (59.4%, n=63) were from the King Edward VIII Hospital (KEH) complex, 22.6% were from Addington Hospital (AH), 16.0% were from R K Khan Hospital (RKKH), and only 1.9% were from private practitioners. Of those with confirmed prostate adenocarcinoma (n=52), 55.8% (n=29) were referred from KEH, 25.0% (n=13) from AH, 17.3% (n=9) from RKKH and 1.9% (n=1) from private practice.
45 40 35 30 25 20 15 10 5 0
Black African
White
Indian
Coloured
Fig. 3. Median PSA levels in the different races with prostate cancer.
The median period of time from referral to biopsy date was 55 days, from referral to first follow-up date 100 days, and from biopsy date to first follow-up date 36 days (Fig. 4). No relationship was observed between referral centre and any of the waiting periods (p>0.05).
Discussion
The patients in this study were more representative of the demographics of the general SA population than the larger 10-year retrospective review of 901 patients with prostate cancer managed by the urological oncology clinic at Tygerberg Hospital, Western Cape, by Heyns et al.[5,16] The Western Cape study[5] demonstrated a predominance (59.8%) of white patients with prostate cancer, black patients accounting for only 32.3%. This differs from the findings of our study, in which there was a predominance of blacks (69.8%, n=74), and whites accounted for only 13.2% (n=14). The median PSA level of our black patients with prostate cancer was 42.2 ng/mL (n=74) and that for whites was 12.8 ng/mL (n=5), in comparison with findings in the Western Cape[5] of 105 ng/mL and 19.6 ng/mL, respectively. Owing to the lack of understanding of the disease profile in KZN, and lack of an updated National Cancer Registry, it is very difficult to draw guidelines, allocate resources and streamline biopsy services with the aim of establishing an efficient service and identifying curable disease. Patients are waiting for an average of 3 months (100 days) from the initial referral date to presumed diagnosis and definitive
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Table 1. Reasons for delay in diagnosis Patient factors
Healthcare provider factors
Infrastructure factors
• Lack of personal health awareness • Only seeking medical intervention when symptomatic or traditional medicine has failed
• Inadequate gatekeeper knowledge of DRE, PSA screening and when to appropriately refer • Belief that prostate cancer is a slowly progressive disease that does not need to be referred timeously
• Lack of dedicated prostate biopsy clinics • Lack of equipment – ultrasound machines with rectal probes and biopsy needles • Overbooked clinics • Lengthy pathology processing time • Inadequate human resource training and allocation
Referral to biopsy (days) 200 300
400
challenge and patients could not be staged adequately. However, almost two-thirds (n=31) of patients with confirmed adenocarcinoma were found to have had advanced disease at presentation. A future larger prospective study should be performed in KZN, similar to that of Heyns et al.,[9] who found that potentially curative treatment could be offered to 37.5% of patients with clinically localised prostate cancer. Postulated reasons for the delay in diagnosis include but are not limited to patient, healthcare provider and infrastructure factors (Table 1).
100
Conclusion
Biopsy to follow-up (days) 100 50
150
0
Before this study, we were uncertain of the scope of pathology encountered at the St Aidan’s Hospital complex. We found that almost half of all patients referred to our service have prostate cancer, and that almost two-thirds of those with histological confirmation of prostate cancer will have metastatic disease at presentation. As shown in other larger studies,[5] the vast majority of black patients with prostate cancer present with high PSA levels, indicating advanced disease in most cases. Patients are waiting an average of 3 months to receive a diagnosis and plan of treatment after being referred. As the number of patients increases with the arrival of NHI, waiting times for treatment are likely to continue to increase, potentially resulting in additional treatment delays.
0
Referral to follow-up (days) 100 200 300
400
0
References
Fig. 4. Waiting times for the different time intervals observed.
management, with only 7.7% (n=4) with prostate cancer qualifying for a potentially curative procedure. It is difficult to comment on this figure further, as lack of adequate record keeping was a major
486
1. Max W, Rice DP, Sung HY, et al. The economic burden of prostate cancer, California, 1998. Cancer 2002;94(11):2906-2913. [http://dx.doi.org/10.1002/cncr.10532] 2. Rebbeck TR, Devesa SS, Chang BL, et al. Global patterns of prostate cancer incidence, aggressiveness, and mortality in men of African descent. Prostate Cancer 2013 (2013), Article ID 560857. [http:// dx.doi.org/10.1155/2013/560857] 3. Boyle P, Levin B. World Cancer Report 2008. Lyon: IARC Press, 2008. 4. Odedina FT, Akinremi TO, Chinegwundoh F, et al. Prostate cancer disparities in black men of African descent: A comparative literature review of prostate cancer burden among black men in the United States, Caribbean, United Kingdom, and West Africa. Infect Agent Cancer 2009;4(Suppl 1):S2. [http:// dx.doi.org/10.1186/1750-9378-4-S1-S2] 5. Heyns CF, Fisher M, Lecuona A, van der Merwe A. Prostate cancer among different racial groups in the Western Cape: Presenting features and management. S Afr Med J 2011;101(4):267-270. 6. Evans HS, Moller H. Recent trends in prostate cancer incidence and mortality in southeast England. Eur Urol 2003;43(4):337-341. [http://dx.doi.org/10.1016/S0302-2838(03)00085-X] 7. Sandblom G, Varenhorst E, Lofman O, et al. Clinical consequences of screening for prostate cancer: 15 years follow-up of a randomised controlled trial in Sweden. Eur Urol 2004;46(7):717-723. [http:// dx.doi.org/10.1016/j.eururo.2004.08.011] 8. Paquette EL, Sun L, Paquette LR, et al. Improved prostate cancer-specific survival and other disease parameters: Impact of prostate-specific antigen testing. Urology 2002;60(5):756-759. [http://dx.doi. org/10.1016/S0090-4295(02)01960-X] 9. Heyns CF, Naude AM, Visser AJ, et al. Early diagnosis of prostate cancer in the Western Cape. S Afr Med J 2001;91(8):679-684. 10. Heyns CF, Mathee S, Isaacs A, Kharwa A, de Beer PM, Pretorius MA. Problems with prostate specific antigen screening for prostate cancer in the primary healthcare setting in South Africa. BJU Int 2003;91(9):785-788. [http://dx.doi.org/10.1046/j.1464-410X.2003.04241.x ] 11. Heyns CF, Naude AM, Ahmed G, Stopforth HB, Stellmacher GA. Serum prostate-specific antigen as a surrogate for the histological diagnosis of prostate cancer. S Afr Med J 2001;91(8):685-689. 12. Heyns CF, van der Merwe A. Prostate specific antigen – brief update on its clinical use. S Afr Fam Pract 2008;50(2):19-24. 13. Heyns CF, van der Merwe A. Prostate cancer management – helping your patient choose what is best for him. S Afr Fam Pract 2008;50(5):27-34. 14. Heyns CF. Urology in South Africa. J Maroc Urol 2006;2:4-6. http://lazraqinfo.com/JMU/PDFn2/ Heynssouthafrica.pdf (accessed 8 May 2015). 15. D’Amico AV, Chen MH, Malkowicz SB, et al. Lower prostate specific antigen outcome than expected following radical prostatectomy in patients with high grade prostate cancer and a prostatic specific antigen level of 4 ng/ml or less. J Urol 2002;167(5):2025-2030; discussion 2030-2031. [http://dx.doi. org/10.1016/S0022-5347(05)65076-8] 16. Census 2011: Census in Brief. Pretoria: Statistics South Africa, 2012.
Accepted 20 January 2015.
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The appropriateness of preoperative blood testing: A retrospective evaluation and cost analysis H E Buley,1 MB ChB; D Bishop,2 MB ChB, FCA (SA); R Rodseth,2,3 MB ChB, FCA (SA), MMed, MSc, PhD epartment of Anaesthesiology and Critical Care, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of D Medicine, University of KwaZulu-Natal, Durban, South Africa 2 Perioperative Research Group, Department of Anaesthetics and Critical Care, School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa 3 Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA 1
Corresponding author: H Buley (helenbuley@gmail.com)
Background. Inappropriate preoperative blood testing can negatively contribute to healthcare costs. Objective. To determine the extent and cost implications of inappropriate preoperative blood testing in adult patients booked for orthopaedic, general or trauma surgical procedures at a regional hospital in KwaZulu-Natal Province, South Africa (SA). Methods. We undertook a retrospective observational study using routine clinical data collected from eligible patient charts. The appropriateness of preoperative blood tests was evaluated against locally published guidelines on testing for elective and non-elective surgery. The cost of the relevant blood tests was determined using the National Health Laboratory Service 2014 State Pricing List. Results. A total of 320 eligible patient charts were reviewed over a 4-week period. Preoperative blood testing was performed in 318 patients. There was poor compliance with current departmental guidelines, with an estimated over-expenditure of ZAR81 019. Non-compliance was particularly prevalent in younger patients, patients graded as American Society of Anesthesiologists 1 and 2, and low-risk surgery groups. Conclusion. Inappropriate preoperative blood testing is common in our hospital, particularly in low-risk patients. This is associated with an increase in healthcare costs, and highlights the need for SA doctors to become more cost-conscious in their approach to blood testing practices. S Afr Med J 2015;105(6):487-490. DOI:10.7196/SAMJ.9318
Preoperative evaluation, including blood testing, is an integral part of providing safe perioperative care. [1] However, routine preoperative blood testing is no longer advocated, as several studies have highlighted the absence of negative outcomes associated with the omission of investigations and the low frequency of abnormal results in healthy patients undergoing low-risk surgery.[2,3] Blood tests should therefore only be conducted when specifically indicated. In many centres, local guidelines have been developed to assist doctors in performing appropriate preoperative investigations. In addition, inappropriate preoperative blood testing is costly.[4,5] This is of particular importance in a highly cost-conscious environment such as the South African (SA) health sector. As stated by the National Treasury in 2013: ‘… departments and spending agencies do have to learn to do more with less. In the period ahead, improvements in outcomes have to come from qualitative improvements in the use of available budgets and other inputs.’[6] The concept of ‘costconsciousness’ among doctors needs to become a more pertinent aspect of daily practice.
Objective
To determine the appropriateness of preoperative blood testing, and possible cost implications, in adult patients booked for orthopaedic, general or trauma surgical procedures at a regional hospital in KwaZulu-Natal Province, SA.
Methods
We conducted a retrospective observational study approved by the hospital manager, KwaZulu-Natal Department of Health, and the University of KwaZulu-Natal Biomedical Research Ethics Committee (Ref: BE345/14). A systematic convenience sampling
487
method was used and data were collected retrospectively from eligible charts on an alternate week (Monday to Sunday) cycle over 8 weeks. This provided a total of 4 weeks of data collection over 2 consecutive months. Only routine clinical data from eligible charts were used. All adult patients (≥18 years of age) undergoing elective or non-elective surgery in the disciplines of general, trauma or orthopaedic surgery were included. Patients requiring surgery while admitted to the intensive care, high-care and burn units were excluded, as were those who had undergone high-risk surgery within the last 6 months. Surgical risk was classified as low or high using previously published criteria.[7] The primary study endpoint was the incidence of inappropriate preoperative blood tests across a range of laboratory tests. Those evaluated were full blood count (FBC), urea, creatinine and electrolytes (UE), liver function testing (LFT), the international normalised ratio (INR), blood gas analyses (ABG), calcium, magnesium and phosphate (CMP), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and albumin. Results were expressed as a percentage of inappropriate tests against the total number of tests performed. The appropriateness of a blood test was determined by the Pietermaritzburg Metropolitan Department of Anaesthesia’s guidelines on preoperative blood testing for elective and non-elective surgery (Appendix 1). Where the appropriateness of preoperative blood testing could not be ascertained clearly, the relevant data were reviewed separately by DB and RR, both anaesthetic consultants familiar with the departmental protocol. The cost implication of unnecessary preoperative blood testing was determined by multiplying the cost of the relevant blood test by the number of unnecessary respective tests performed in the sample. The cost of the relevant blood tests was obtained from the National Health Laboratory Service (NHLS) 2014 State Pricing List.
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Results
Cohort characteristics
A total of 320 eligible patient charts were reviewed, and the characteristics of the cohort are summarised in Table 1. The majority of surgical procedures at the study hospital are done on low-risk patients (81.9%), patients who are ≤60 years of age (84.4%) and those who have an American Society of Anesthesiologists (ASA) physical status grading of 1 or 2 (86.9%). Comorbidities observed included asthma, diabetes, vascular disease, hypertension, epilepsy and HIV infection. The charts reflected 131 (40.9%) general surgical, 15 (4.7%) trauma and 174 (54.4%) orthopaedic surgery cases.
Preoperative testing practices
New preoperative blood testing was performed either on admission or before surgery on all but two of the 320 patients evaluated. Only one patient had no preoperative testing performed, and one patient had results from the referral hospital with no subsequent testing. Eight of the included patients had more than one surgical procedure, with no repeat testing between procedures. The most commonly performed preoperative blood tests were an FBC (310) and UE (310). Additional frequently performed tests included LFT, INR, ABG, CMP, CRP, ESR and albumin. Observed preoperative testing practices are summarised in Table 2. Inappropriate tests included 190 FBCs (61.3%), 206 UEs (66.4%), 92 LFTs (97.9%) and 49 INRs (92.5%). The majority of patients who received inappropriate tests were <45 years of age, graded as ASA 1, or undergoing a low-risk surgical procedure. In addition, we noted that four patients were discharged after surgery without their blood results being documented in their files. Further, in 60 charts the FBC and
UE were repeated perioperatively without any clear indication, and in seven charts admission blood tests were performed twice within 24 hours. With no clearly delineated surgical, trauma or orthopaedic preoperative guidelines, it was not possible to determine the appropriateness of blood testing for surgical purposes relative to anaesthetic indications. The documentation of blood results on anaesthetic forms was also reviewed. No blood results were documented on 11.9% of charts, 24.0% of charts had documented ward haemoglobin only, and 1.6% had a blood gas result only. Adequate documentation for appropriate FBCs and UEs was observed in 70.0% and 67.3% of charts, respectively. Despite the high prevalence of unnecessary blood testing, there was also inadequate documentation of appropriate tests on the anaesthetic charts.
Cost implications
The total cost of the inappropriate tests performed was ZAR72 375. The largest contributors to this included 92 LFTs (ZAR29 349), 206 UEs (ZAR15 817) and the combined group of CMP, albumin, ESR and CRP (ZAR12 566). The cost of repeat and duplicate testing practices that were observed was ZAR8 643. In total, the estimated cost of unnecessary perioperative testing in a 4-week period was ZAR81 018.
Discussion
This study demonstrates that inappropriate blood testing is common in patients booked for both elective and non-elective orthopaedic, trauma or general surgical procedures – this despite the existence of locally developed anaesthetic preoperative testing guidelines. The majority of procedures that take place at the study hospital involve low-risk surgery in patients
<60 years of age and with an ASA grading of 1 or 2. These patient groups undergo unnecessary testing that has significant cost implications. The role of preoperative blood testing is to assist in the detection of abnormalities that could alter patient management and lead to better outcomes. In a recent study, Benarroch-Gampel et al.[3] examined patterns of preoperative blood testing in 73 596 patients undergoing elective hernia repair, of whom 46 977 underwent testing. Tests included FBC, creatinine, electrolytes, LFT and coagulation parameters. Their findings suggested that a large proportion of testing for low-risk ambulatory surgery, even in patients with stable comorbid illness, is of questionable clinical benefit and can
Table 1. Cohort characteristics of the charts reviewed (N=320) n (%) Surgical risk Low risk
262 (81.9)
High risk
58 (18.1)
Surgical urgency Non-elective
178 (55.6)
Elective
142 (44.4)
Age group (years) <45
203 (63.4)
45 - 60
67 (20.9)
61 - 75
42 (13.1)
>75
8 (2.5)
ASA grading 1
137 (42.8)
2
141 (44.1)
3
39 (12.2)
4
3 (0.9)
Table 2. Observed preoperative testing practices Age group (years) n (%)
ASA grading n (%)
Blood test
Total N
Surgical risk low n (%)
<45
45 - 60
>61
1 and 2
3
4
FBC
310
253 (81.6)
195 (62.9)
67 (21.6)
48 (15.5)
270 (87.1)
37 (11.9)
3 (1.0)
UE
310
253 (81.6)
194 (62.9)
67 (21.6)
49 (15.8)
269 (86.8)
38 (12.3)
3 (1.0)
LFT
94
65 (69.1)
54 (57.4)
21 (22.3)
19 (20.2)
75 (79.8)
17 (18.1)
2 (2.1)
CMP
81
65 (80.2)
41 (50.6)
20 (24.7)
20 (24.7)
62 (76.5)
18 (22.2)
1 (1.2)
CRP
55
44 (80.0)
38 (69.1)
10 (18.2)
7 (12.7)
49 (89.1)
6 (10.9)
-
ABG
54
35 (64.8)
33 (61.1)
14 (25.9)
7 (13.0)
43 (79.6)
9 (16.7)
2 (3.7)
INR
53
43 (81.1)
27 (50.9)
15 (28.3)
11 (20.8)
39 (73.6)
12 (22.6)
2 (3.8)
ESR
41
32 (78.0)
29 (70.7)
7 (17.1)
5 (12.2)
38 (92.7)
3 (7.3)
-
Albumin
35
28 (80.0)
15 (42.9)
12 (34.3)
8 (22.9)
28 (80.0)
6 (17.1)
1 (2.9)
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be eliminated without significant adverse medical consequences. Surgical indications for specific tests must also be addressed, e.g. LFTs, albumin, ESR, CRP and CMP. Their place in perioperative care needs to be challenged, especially in young, healthy patients undergoing low-risk surgery. Lilford et al.[8] reviewed a cohort of 1 290 patients with abnormal LFT results. They concluded that LFT was associated with a high false-positive rate and often performed for reasons other than that of clinical indication. They advocate a more selective approach to LFT instead of screening all liver enzymes. Albumin is a controversial biomarker of nutritional status, as many other factors, including inflammation, metabolic stress, trauma and dehydration, can affect serum levels.[9] Studies suggest that it can be used as a prognostic marker to identify those at risk of complications following surgery and poor postoperative outcome.[9] However, this is not applicable in patients undergoing lowrisk surgery. Both the ESR and CRP are nonspecific tests that reflect inflammation associated with infection or autoimmune disease. CRP in particular can be used as a monitor for postoperative infection and could assist in identifying patients who are developing severe sepsis.[10] However, once again their indication in the healthy patient undergoing low-risk surgery must be questioned. Disorders in mineral metabolism are complex. Multiple organ systems, in particular the bone mineral content, neurological and cardiovascular systems, can be affected by altered levels of calcium, magnesium and phosphate.[11] Critical illness can have various effects on CMP levels, for multiple reasons. This would justify regular CMP monitoring in critical illness. However, CMP testing in the majority of patients is of questionable value without clear clinical indications. Numerous international studies have highlighted the cost implications of inappropriate blood testing.[4,5] It must also be emphasised that testing not only has financial implications but means unnecessary discomfort to patients, increased occupational exposure to the risk of needlestick injuries, and time lost through acquiring blood samples, waiting for results and addressing false-positive tests. Perioperative care should be a multi disciplinary process involving both the surgeon and the anaesthetist. Addressing unnecessary preoperative blood testing practices should not be the sole responsibility of the surgeon or the anaesthetist, but
rather a process of information sharing and resource management. This study highlights that inappropriate preoperative blood testing is evident despite available anaesthetic guidelines. Reasons for non-compliance were not explored in this study. However, a qualitative study by Brown and Brown[12] identified various factors responsible for unnecessary testing despite available guidelines. These included: (i) lack of awareness of guidelines; (ii) medicolegal concerns; (iii) concern about surgical delays or cancellations; and (iv) the belief that other physicians may require the test results. Surgeons and anaesthetists need to collaborate to ensure knowledge translation and together address implementation issues around current preoperative testing guidelines. Administrative interventions must also be instituted.[13] The NHLS has implemented some of these through electronic gatekeeping, limiting volumes and type of tests ordered, but this tool is not yet available at all state hospitals.[14] Further examples of such interventions include: (i) modification of laboratory request forms to limit available options; (ii) imposing a specific time interval on subsequent testing to prevent repeat testing; (iii) restricting the ordering of specific tests to consultant request only; and (iv) encouraging a selective testing approach, as summarised in Table 3. Finally, the current literature on preoperative testing is based on US,
Canadian or European population groups. The SA population has lower socioeconomic living conditions than those in the northern hemisphere, and disease profiles differ. There is no literature validating preoperative testing guidelines appropriate to the SA population at present, and future studies are required. Reasons behind local preoperative blood testing practices and non-compliance with guidelines also need to be explored and addressed.
Study limitations
Given that this was a retrospective study, all study data were limited by the subjectivity of the attending doctorâ&#x20AC;&#x2122;s assessment of the clinical condition of the patient and the ASA grading. Furthermore, at the time of the study, no clearly delineated surgical or orthopaedic guidelines were available regarding preoperative investigations required.
Conclusion
This study demonstrates that inappropriate blood testing often occurs in patients booked for elective and non-elective general, orthopaedic and trauma surgical procedures, and that it was common in the younger patient, ASA 1 or 2 and low-risk surgery groups. Mis- and overutilisation of blood testing has a significant impact on healthcare costs. SA doctors need to become more cost-conscious in their approach to laboratory testing practices in preoperative patients.
Table 3. Options available for a selective testing approach Test required
Test options
Cost implications
Hb
FBC
ZAR52.23
FBC and Differential
ZAR80.87 (ZAR52.23 + ZAR28.64)
Hb only
ZAR16.24
Hb POCT*
Unknown: cost-effective[15]
Albumin only
ZAR36.23
Albumin as part of an LFT
ZAR319.01
LFT
ZAR319.01
Albumin LFT
Selective test
CMP
Bilirubin total
ZAR31.77
Liver enzyme
ZAR40.91
Protein total
ZAR23.48
CMP
ZAR81.96
Selective test Calcium only
ZAR27.32
Magnesium only
ZAR27.32
Phosphate only
ZAR27.32
Hb = haemoglobin; POCT = point-of-care testing. *Hb POCT together with clinical findings.
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References 1. Task Force on Preanesthesia Evaluation. Practice advisory for preanesthesia evaluation: A report by the American Society of Anesthesiologists Task Force on preanesthesia evaluation. Anesthesiology 2002;96(2):485-496. [http://dx.doi.org/10.1097/00000542-200202000-00037] 2. Kumar A, Srivastava U. Role of routine investigations in preoperative evaluation. J Anaesthesiol Clin Pharmacol 2011;27(2):174-179. [http://dx.doi.org/10.4103/0970-9185.81824] 3. Benarroch-Gampel J, Sheffield KM, Duncan CB, et al. Preoperative laboratory testing in patients undergoing elective, low-risk ambulatory surgery. Ann Surg 2012;256(3):518-528. [http://dx.doi. org/10.1097/SLA.0b013e318256bcdb] 4. Mancuso CA. Impact of new guidelines on physiciansâ&#x20AC;&#x2122; ordering of preoperative tests. J Gen Intern Med 1999;14(3):166-172. [http://dx.doi.org/10.1046/j.1525-1497.1999.00308.x] 5. Siriussawakul A, Nimmannit A, Rattana-arpa S, et al. Evaluating compliance with international preoperative testing guidelines for minimal-risk patients undergoing elective surgery. Biomed Res Int 2013;2013: Article ID 835426. [http;//dx.doi.org/10.1155/2013/835426] 6. Fuzile L. Estimates of National Expenditure 2013. Pretoria: National Treasury, Republic of South Africa, 2013:5. http://www.treasury.gov.za/documents/national%20budget/2013 (accessed 11 May 2015). 7. Devereau PJ, Chan MTV, Alonso-Coello P, et al. Association between postoperative troponin levels and 30 day mortality among patients undergoing noncardiac surgery. JAMA 2012;307(21):2295-2304. [http://dx.doi.org/10.1001/jama.2012.5502]
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8. Lilford RJ, Bentham L, Girling A, et al. Birmingham and Lambeth liver evaluation testing strategies (BALLETS): A prospective cohort study. Health Technol Assess 2013;17(28):i-xiv,1-307. [http://dx.doi.org/10.3310/hta17280] 9. Basu I, Subramanian P, Prime M, et al. The use of biochemical parameters as nutritional screening tools in surgical patients. Surgical Science 2011;2(2):89-94. [http://dx.doi.org/10.4236/ss.2011.22019] 10. Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci 2013;50(1):23-36. [http://dx.doi.org/10.3109/10 408363.2013.764490] 11. Baker SB, Worthley LIG. The essentials of calcium, magnesium and phosphate metabolism: Part II. Disorders. Crit Care Resusc 2002;4(4):307-315. [PMID: 16573444] 12. Brown SR, Brown J. Why do physicians order unnecessary preoperative tests? A qualitative study. Fam Med 2011;43(5):338-343. 13. Stuebing EA, Milner TJ. Surgical vampires and rising health care expenditure. Arch Surg 2011;146(5):524-527. [http://dx.doi.org/10.1001/archsurg.2011.103] 14. Pillay S. National Health Laboratory Service Annual Report 2013-2014. Johannesburg: National Health Laboratory Service, 2014:12. 15. Mimoz O, Frasca D, MĂŠdard A, et al. Reliability of the HemoCue@ hemoglobinometer in critically ill patients: A prospective observational study. Minerva Anestesiol 2011;77(10):979-985.
Accepted 21 April 2015.
June 2015, Vol. 105, No. 6
<6/12
<1/12
<6/12
CCF
Previous DVT/PE
June 2015, Vol. 105, No. 6
Investigations required for this patient
Clinical immune suppression
Burns acute >15%
TIA, blackouts, CVA
Anticoagulants
Steriod use
Smoking >20 pack year
Diabetes Diabetes complicated by vascular disease
Blood disorders
Renal disease
CXR
<6/12
<6/12
<1/12
Malignancy
Hepatic disease/ethanol
<6/12
COAD
Severe asthma or recent admission
ECG
<1/12
<1/12
<1/12
FBC
<1/12
<1/12
<1/12
<1/12
Clinical
<1/12
Type & screen INR/PTT U & E Glucose
<1/12
<1/12
<1/12
Clinical <1/12
Asthma controlled
Hypertension
<1/12 <1/12
<1/12
<1/12
Type & screen INR/PTT U & E Glucose
<1/12
<1/12
<1/12
<1/12
ward Hb
FBC
<6/12
<1/12
<1/12
ECG
Valvular heart disease
Dysrhythmia
Clinical
Unstable angina, prev MI
<6/12
IHD stable angina
Anaemia
Age >75
Age 60 - 75
Age 45 - 60
Age <45
Surgical procedure requiring type and screen
CXR
LFT
<1/12
<1/12
LFT
Peak flow
Peak flow
PFT
Severe disease
PFT
Anaesthetic clinic
TIA, Blackout
Renal failure
Severe disease
Poorly controlled
Symptomatic
Rapid AF medical consult first
Anaesthetic clinic
Other
Coagulation profile
Cardiology notes Cardiology notes
See MSBOS
Other
PMB Metropolitan Department of Anaesthesia Preoperative Testing
Reproduced with permission from Dr N Hendricks.
Anaesthetic Medical consult consult
Anaesthetic Medical consult consult
Clinical
<6/12
<1/12
Investigation not required
Investigation pending clinical requirement
Investigation <6/12 old acceptable
Investigation <1/12 old acceptable
investigation required
Appendix 1. Pietermaritzburg Metropolitan Department of Anaesthesia preoperative testing guidelines
RESEARCH
RESEARCH
Analysis of referrals and triage patterns in a South African metropolitan adult intensive care service K Gordon,1 MB ChB, DA (SA); N Allorto,2 MB ChB, MMed (Surg), FCS (SA); R Wise,3 MB ChB, FCA (SA), MMed (Anaes), Cert Crit Care (SA) epartment of Anaesthetics, Inkosi Albert Luthuli Central Hospital and School of Clinical Medicine, College of Health Sciences, Nelson R D Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa 2 Department of Surgery, Edendale Hospital, Pietermaritzburg, and School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa 3 Department of Anaesthetics and Critical Care, Edendale Hospital, Pietermaritzburg, and School of Clinical Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa 1
Corresponding author: K Gordon (kategordon0@gmail.com)
Background. Intensive care unit (ICU) beds are scarce resources in low- and middle-income countries. Currently there is little literature that quantifies the extent of the demand placed on these resources or examines their allocation. Objectives. To analyse the number and nature of referrals to ICUs in the Pietermaritzburg metropolitan area, South Africa, over a 1-year period, to observe the triage process involved in selecting patients for admission. Methods. A retrospective review of the patients referred to ICUs at Grey’s and Edendale hospitals, Pietermaritzburg, was performed over a year. The spectrum of patients was evaluated with respect to various demographics, and the current triage process was observed. Results. The Pietermaritzburg Metropolitan Critical Care service (PMCCS) received 2 081 patient referrals, 53.4% (1 111/2 081) of males and 46.6% (970/2 081) of females, with a mean patient age of 32 years. The majority of referrals were of surgical patients (39.3%, 818/2 081), followed by medical (18.9%, 393/2 081), trauma (18.6%, 387/2 081) and obstetrics and gynaecology (11.7%, 244/2 081). The chief indications for referral were the need for cardiovascular and respiratory support. Of these referrals, 72.0% (1 499/2 081) were accepted and planned for admission and 28.0% (582/2 081) were refused ICU care. Of the patients accepted, 60.7% (910/1 499) experienced delays prior to admission and 37.4% (561/1 499) were never physically admitted to the units. Conclusions. The PMCCS receives a far greater number of patient referrals than it is able to accommodate, necessitating triage. Patient demographics reflect a young patient population referred with chiefly surgical pathology needing physiological support. S Afr Med J 2015;105(6):491-495. DOI:10.7196/SAMJ.9007
Critical care is currently faced with the challenge of resource scarcity and an exponentially increasing demand for intensive care unit (ICU) management. [1] Although this problem is fairly well represented in high-income country (HIC) research, limited literature exists to quantify the burden of critical illness in low- and middle-income countries (LMICs).[2-5] While South Africa (SA) has published data regarding national ICU resources, little is known about the demand placed on them.[6-9] Global resource restrictions and the growing burden of critical illness necessitate daily ICU triage. This has become an essential step in facilitating efficient utilisation of available ICU facilities, enabling the largest number of patients to benefit.[1-2] However, little consensus exists in terms of how best to conduct this triage, and available international guidelines do not translate well into an LMIC context.[10-11]
Background
The Pietermaritzburg Metropolitan Critical Care service (PMCCS), located in KwaZulu-Natal Province (KZN), SA, comprises two public hospitals. Grey’s Hospital is a tertiary hospital with 420-bed capacity and a six-bed ICU. Edendale Hospital, a 900-bed regional hospital, has a six-bed ICU and a three-bed high-care unit (HCU). A 1:1 nurse-to-patient ratio is employed with ICU patients and a 1:2 ratio with HCU patients. Both critical care units are closed, intensivist-led units with the same admission and discharge criteria. The same triage process is utilised by both.
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Referral to these units is by formalised written request made on a standardised form. A critical care team member reviews each of the referrals in person. Patients are triaged using the Society of Critical Care Medicine (SCCM) prioritisation model, whereby they are classified according to the severity of their illness, background pathology and prognosis into groups I - IV (Table 1) then either accepted for or refused ICU care.[1] Patients refused on the basis of being too well may be re-referred should their condition deteriorate, but patients deemed too sick are not reconsidered without some form of motivation. Refusal of admission to an ICU is made on the basis of no perceived benefit for the patient. All patients deemed to derive benefit from ICU management are accepted for admission. Frequent shortages in ICU resources result in delays in admission for some accepted patients. Patients are never refused admission because of a lack of ICU beds, but are rather accepted pending bed availability. Critical care team members review these patients on the wards and guide their management in the form of outreach care. Patients accepted for ICU care are therefore not necessarily always physically admitted to the units.
Objectives
To quantify the current demand for ICU beds in an SA metropolitan area (Pietermaritzburg metropolitan area) and appreciate this region’s patient demographics and case mix. The prioritisation process employed to triage referrals was also examined, as were the setbacks encountered during the process of admission to an ICU.
June 2015, Vol. 105, No. 6
RESEARCH
Methods
A retrospective review of all of the patients referred to the ICUs at Grey’s and Edendale hospitals over the course of a year was undertaken. The referral proformas generated from both hospitals from March 2013 to the end of February 2014 were used to create a database. The weekly proformas gathered specific data regarding referrals, including basic patient demographics, reason for the referral, acceptance or refusal of admission, and the reason for refusal. Accepted patients were then further divided into those admitted immediately and those who experienced a delayed admission. Reasons for delays were documented. All patients over the age of 12 years referred to the ICUs at Grey’s or Edendale hospitals were included in the study. Referred children less than 12 years of age were excluded, as both units are adult ICUs and the occasional paediatric admission therefore does not reflect the burden of paediatric ICU referrals. No patient identifiers were used. The data were collected retrospectively and therefore indicate practice in the unit. No steps or interventions were undertaken to alter this current practice. Descriptive statistics were used to describe the results.
Results
The PMCCS received a total of 2 081 referrals over a 1-year period (Fig. 1). These referrals consisted of 970 female patients (46.6%) and 1 111 males (53.4%) (Table 2). The majority were between 21 and 40 years old (mean age 32 years, range 13 - 108). General surgery was the discipline referring the most patients, with 818 requests (39.3%). Internal medicine, trauma surgery and obstetrics and gynaecology represented 18.9% (393/2 081), 18.6% (387/2 081) and 11.7% (244/2 081) of referrals, respectively (Table 2). The reasons for referral were primarily for cardiovascular support (19.8%, 413/2 081) and respiratory support (19.7%, 410/2 081). Other reasons included the management of sepsis (13.1%, 273/2 081), metabolic support (11.9%, 247/2 081), neuroprotection (10.3%, 214/2 081), correction of coagulopathy (8.3%, 172/2 081), renal replacement therapy (6.6%, 138/2 081), airway protection (5.0%, 104/2 081) and epidural care and analgesia (5.3%, 110/2 081) (Table 2). The SCCM prioritisation system indicated that the highest number of referrals (38.5%, 802/2 081) fell into category I. Category II referrals constituted 21.1% of patients (440/2 081), category III 12.3% (257/2 081), and category IV 28.0% (582/2 081) (Table 1). Of the patients referred, 1 499 (72.0%) were accepted for admission and 582 were
refused (Fig. 1). Those refused were either considered too well (53.6%, 312/582) or too severely ill (46.4%, 270/582) to benefit from ICU care. The patients accepted for admission into the unit were representative of the referrals pool. The mean age of patients accepted was 32 years, with 40.1% (601/1 499) falling into the 21 - 40-year age group. Of the patients accepted, 45.4% were females (680/1 499) and 54.6% (819/1 499) males. General surgery represented the referring discipline in 39.9% (598/1 499) of the patients accepted for admission, trauma surgery 20.3% (304/1 499), internal medicine 15.9% (238/1 499), and obstetrics and gynaecology 12.2% (183/1 499) (Table 2). The reasons for admission were primarily cardiovascular and respiratory support, in keeping with the main reasons for referral (Table 2). Of the patients accepted for admission, 39.3% (589/1 499) were admitted imme diately and the remaining 60.7% (910/1 499) experienced a delay in admission. Delays were predominantly due to resource shor tages (Fig. 2). ‘No available bed’ and ‘no available ICU nurse’ contributed to 64.6% (588/910) and 7.0% (64/910) of the delays, respectively. The remainder of the delayed admissions were due to patients undergoing surgery, who were either referred preoperatively (15.8%, 144/910) or intraoperatively (12.5%, 114/910). As a result of these delays, 37.4% (561/1 499) of patients accepted for ICU management were never physically admitted into the units. The reasons varied, and are
illustrated in Fig. 3. They showed a degree of clinical improvement that meant that their admission was no longer warranted (54.2%, 304/561), had an elective surgical procedure cancelled (13.4%, 75/561), were transferred to another ICU outside the metropolitan area (20.5%, 115/561), deteriorated to an irreversible point (3.9%, 22/561) or died (8.0%, 45/561).
Discussion
Critical care in SA
Critical care in SA faces unique challenges. Not only must it contend with the global issue of resource constraints, but a national focus on primary healthcare has meant that development of additional infrastructure has not occurred.[6,9] Only 23% of all public hospitals are equipped with ICU facilities.[6] Furthermore, disparities in health resource distribution mean that ICUs tend to be located in urban areas, with rural areas having limited or no such facilities.[7] Patient transport services are limited, making inter-hospital transfers tenuous.[7] Disparities in quality of care between units are also recognised, with only 7% of all public sector units functioning in an ideal ‘closed’ capacity.[6] The well-equipped, specialist-run ICUs in academic hospitals contrast starkly with the basic units that are in operation in regional community hospitals.[8,9] Staff shortages, including shortages of critical care specialists and ICU-trained nurses, are a common problem throughout the country.[8] Guidelines such as those proposed by the American Leapfrog Group regarding goldstandard ICU staffing (critical care specialist-
Table 1. SCCM prioritisation categories[1] of the patients referred to the ICUs (N=2 081) SCCM category
Patient characteristics
n (%)
I
Critically ill requiring active physiological support
802 (38.5)
II
Not currently critically ill but at risk of becoming so, intensive monitoring required
440 (21.1)
III
Critically ill requiring active physiological support but with guarded prognosis owing to associated illness
257 (12.3)
IV a
Too well to warrant ICU admission
312 (15.0)
IV b
Critically ill with irreversible physiological failure facing imminent death
270 (13.0)
Total ICU referrals N=2 081 (100%)
Accepted to ICU n=1 499 (72%)
Refused ICU n=582 (28%)
No delay in admission n=589 (39%) Admission delayed n=910 (61%)
Admitted to ICU n=349 (38%) Never admitted to ICU n=561 (62%)
Fig. 1 Algorithm of the process of candidate triage for ICU admission and the number of patients comprising each group.
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RESEARCH
run, closed ICU staffed by ICU-trained nurses) therefore appear unrealistic in the SA setting.[12]
Table 2. Demographics of the patients referred to the ICUs (N=2 081) Demographic
Accepted n (%)
Refused n (%)
Total n (%)
Total patients referred
1 499 (72.0)
582 (28.0)
2 081 (100.0)
Female
680 (45.4)
290 (49.8)
970 (46.6)
Male
819 (54.6)
292 (50.2)
1 111 (53.4)
206 (13.7)
58 (10.0)
264 (12.7)
Gender
Age (years) <20 21 - 40
601 (40.1)
233 (40.0)
834 (40.1)
41 - 60
418 (27.9)
176 (30.2)
594 (28.5)
>61
274 (18.3)
115 (19.8)
389 (18.7)
Referring discipline Internal medicine
238 (15.9)
155 (26.6)
393 (18.9)
Burns
25 (1.7)
9 (1.5)
34 (1.6)
General surgery
598 (39.9)
220 (37.8)
818 (39.3)
Trauma surgery
304 (20.3)
83 (14.3)
387 (18.6)
Obstetrics & gynaecology
183 (12.2)
61 (10.5)
244 (11.7)
Orthopaedics
77 (5.1)
33 (5.7)
110 (5.3)
Urology
63 (4.2)
20 (3.4)
83 (4.0)
Other
11 (0.7)
1 (0.2)
12 (0.6)
Reason for referral Airway protection
86 (5.7)
18 (3.1)
104 (5.0)
Ventilatory support
285 (19.0)
125 (21.5)
410 (19.7)
Haemodynamic support
316 (21.1)
97 (16.7)
413 (19.8)
Neuroprotection
135 (9.0)
79 (13.6)
214 (10.3)
Renal replacement
95 (6.3)
43 (7.4)
138 (6.6)
Metabolic support
159 (10.6)
88 (15.1)
247 (11.9)
Management of sepsis
188 (12.5)
85 (14.6)
273 (13.1)
Coagulopathy correction
130 (8.7)
42 (7.2)
172 (8.3)
Analgesia
105 (7.0)
5 (0.8)
110 (5.3)
ICUs in the Pietermaritzburg metropolitan area
The Pietermaritzburg metropolitan area is located in KZN, an urbanised province where access to ICU facilities is relatively good, although the ratio of public ICU beds to population is 1:32 000.[9] KZN is a resource-poor setting when compared with international standards such as those in the USA or Germany, where 5 000 and 4 065 individuals, respectively, are served by each ICU bed.[5] Compounding the issue of scarcity is a significantly higher burden of illness and critical illness in this LMIC.[3] Unfortunately, limited evidence currently exists to confirm that the number of ICU beds in KZN is inadequate to serve the population, and data are needed to quantify the extent of the pressure placed on these limited resources. This study indicates that the demand for ICU beds in the Pietermaritzburg metropolitan area outstrips what is currently available. The two units have 12 ICU beds and 3 HCU beds between them. Our study findings make this deficiency in resources clear – over the course of a year, 2 081 patients were referred to the units but only 938 could be accommodated and were admitted for critical care management (589/938 admitted immediately and 349/938 after a delay). Of the 1 143 patients who were not physically admitted to the units, 556 (48.6%) were considered likely to benefit from ICU management. They included 181 SCCM I patients, 198 SCCM II patients and 177 SCCM III patients. This shows an extreme disparity between need and available resources.
Patient demographics and case-mix of total referrals
114/910 12.5% No bed No staff
144/910 15.8%
Preop Intraop
64/910 7.0% 588/910 64.1%
Fig. 2. Reasons for delayed admission to the ICUs.
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Analysis of the patients referred to critical care revealed a fairly equal maleto-female ratio. This contrasts with the only other available SA data, from Chris Hani Baragwanath Academic Hospital in Johannesburg, where a preponderance of male patients was noted as a result of a heavy trauma load.[13] In contrast, our burden of illness is significantly different, general surgery accounting for the greatest number of referrals, while trauma was on par with internal medicine and obstetrics and gynaecology. A possible explanation for the un expectedly low number of trauma referrals may be that a relatively large subgroup of patients with severe traumatic brain injuries
RESEARCH
It is at this point of the process that the triage algorithm in its current form is flawed, as it fails to account for the scarcity of ICU resources. Many of those who are accepted will never be admitted, and if admission occurs it may be delayed, which can have a negative impact on prognosis.
and/or inotropic therapy. These trends support the idea that the more limited the availability of ICU beds, the more this resource must be reserved for active physiological support of severely ill patients rather than for intensive monitoring purposes.[3-5,5] The ICU at Grey’s Hospital is primarily a surgical unit, while that at Edendale Hospital caters for a mix of surgical and medical patients. It is therefore to be expected that these units will see a relatively high proportion of surgical patients. There are also a significant number of patients (5.3%) accepted for analgesic-related care (primarily epidural management), which according to hospital protocol is not carried out on the wards. Although this number appears high and may indicate a tendency on the part of anaesthetist intensivists to accept more patients for this indication, analgesic care may be necessary to prevent secondary reasons for referral, i.e. respiratory failure in patients with chest trauma. The PMCCS is staffed by a range of physician, surgical and anaesthetist intensivists, and the potential for specialty-related bias in accepting or refusing patients for admission is reduced by the application of the objective SCCM prioritisation model and interdisciplinary discussion.
Refusal of patients referred
Study limitations
75/561 13.4% Became too well Became too sick Died Transferred Op cancelled 115/561 20.5%
304/561 54.2%
45/561 8.0% 22/561 3.9%
Fig. 3. Reasons why delayed patients were never admitted to the ICUs.
are often not referred for critical care and neuroprotection owing to a perceived lack of critical care resources or poor prognosis. This hypothesis needs to be explored in future studies. The ICU at Grey’s Hospital also functions as a predominantly surgical ICU, a fact that may have hindered referral of medical patients to the unit. KZN has one of the highest HIV prevalence rates in the world.[14] The contribution of HIV to the burden of illness in local critical care patients has not been described, but may influence the current case mix in these units. The main reasons for referral, a need for active physiological support in an acute setting, appear similar to those seen in other local units and in other LIMCs.[3,4,15] The mean age, which is low when compared with HIC ICUs, is to be expected in SA where average life expectancy is 59.6 years. [3-5,15] However, the wide age range illustrates that we are not immune to the international trend of a growing aged population.
Local triage process
Owing to the supply-demand mismatch of ICU resources, every patient referred undergoes ICU triage. The first step of this triage decision is to exclude and refuse inappropriate referrals – those patients deemed either too well or too ill to benefit from an ICU bed rather than one in a general ward. All the remaining patients were accepted as good candidates for ICU admission. Accepted patients are prioritised using the SCCM model according to the severity of their illness and their long-term prognosis.[1] SCCM I patients are admitted ahead of SCCM II and SCCM III patients. [1]
A significant proportion of our referrals (28.0%, 582/2 081) were refused. When comparing this figure with international data, it should be borne in mind that many of the refusals in HICs are on the basis of no available bed.[1,2,16] In our study, no patient was refused on the basis of no bed, but patients were accepted for admission pending availability of a bed. This discrepancy in detail reduces the significance of comparisons between our study population and international trends. However, if we considered all the patients who were referred and not physically admitted to the units, the figure of 54.9% (1 143/2 081) is significantly higher than current international standards. Triage stati stics from the USA quote a figure of 15% of referrals refused admission, while in the UK up to 21% of all patients referred are refused admission.[1,2,16]
Accepted patient demographics and case mix
The demographics of patients accepted for admission to our units are similar to those in resource-poor units in other LMICs.[3,4,15] They tend to be relatively young patients with surgical pathologies, admitted for physiological support, specifically ventilation
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This study had a retrospective observa tional design and is susceptible to bias. The proformas were completed on a weekly basis by a different investigator each week. Data collected were therefore subject to inter-individual interpretations. Although several of the patient demographics were standardised in terms of definitions, for example age, gender, referring discipline and SCCM classification, others were less well defined, with the reason for referral being the most problematic. A patient referred with septic shock and requiring inotropic therapy may, for example, have been classified as ‘sepsis’ or ‘cardiovascular support’, depending on the investigator completing the proforma. This factor rendered this category of data particularly poor. Data collection was not complete, with 4 weeks of data missing from each institution. In addition, it should be borne in mind that many referrals may not have been made, the referring disciplines recognising the ICU bed shortages; some patients who required ICU management may therefore have never been referred.
Implications for the future
There is no international consensus on the ideal number of ICU beds per population. [16]
RESEARCH
The currently available resources in KZN mean that only 45% of all patients referred may be accommodated in the ICUs, with delays in admission being an unfortunate reality. It is likely that a growing population will continue to outstrip critical care resources.[3] Steps need to be taken in terms of health policy to improve this situation. Further research in this field should describe the demand for critical care on a national level, and once this has been quantified, planning should address the current deficits in resources. The nature of our resource-constrained setting may make this ideal difficult to accomplish. Critics may argue that the cost of development and maintenance of critical care resources could be better spent on the provision of basic primary healthcare. However, an examination of the local patient profile defends the need for improvement in ICU services. Patients are young, with potentially reversible, acute surgical pathologies, and would benefit greatly from active physiological support. It would seem that appropriate planning and simple interventions could save many lives.[3] In the interim, the current triage system needs to take into account the limits of our available critical care resources. The management of patients who are accepted but face delayed admission owing to shortages of resources needs to be re-evaluated. A possibility includes follow-up for future admission for the SCCM I and II patients only. Although the outreach care provided to patients who are accepted but not admitted seems beneficial, it should be recognised that this form of care places pressure on the critical care team member reviewing these patients on the wards. Such an outreach service may also potentially compromise care of patients already in the critical care units, particularly at night, when a single doctor has to oversee ICU patient care. The impact of critical care patients who cannot be accommodated in the ICU on the other services in the hospitals also needs to be investigated. Emergency surgical patients who require postoperative critical care frequently spend extended periods in theatre awaiting an available ICU bed. This delay has a knock-on effect, generating backlogs in theatre and resulting in other emergency surgeries being delayed as the anaesthetist continues to provide critical care services to the patient who is waiting.
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Conclusion
This study reveals that the PMCCS is unable to accommodate the majority of patients referred. Patient demographics reflect a slight male predominance in a young patient population referred with chiefly surgical diagnoses, typically for various forms of physiological support in the ICU. These admission trends mirror those of other resource-limited units. The experience of this unit in SA, an LMIC, is alarming when compared with that of HICs and mandates significant planning at a national level in the future. References 1. Task Force of the American College of Critical Care Medicine, Society of Critical Care Medicine. Guidelines for ICU admission; discharge and triage. Crit Care Med 1999;27(3):633-638. [http://dx.doi. org/10.1007/s003900050275] 2. Scheuremann LP, White DB. The ethics and reality of rationing in medicine. Chest 2011;140(6):16251632. [http://dx.doi.org/10.1378/chest.11-0622] 3. Fowler R, Adhikari NK, Bhagwanjee S. Clinical review: Critical care in the global context – disparities in burden of illness, access and economics. Crit Care 2008;12(5):225-230. [http://dx.doi.org/10.1186/ cc6984] 4. Murthy S, Wunsch H. Clinical review: International comparisons in critical care – lessons learned. Crit Care 2012;16(2):218-224. [http://dx.doi.org/10.1186/cc11140] 5. Prin M, Wunsch H. International comparisons of intensive care: Informing outcomes and improving standards. Curr Opin Crit Care 2012:18(6):700-706. [http://dx.doi.org/10.1097/ MCC.0b013e32835914d5] 6. Scribante J, Bhagwanjee S. National audit of critical care resources in South Africa – open versus closed intensive and high care units. S Afr Med J 2007;97(12):1319-1322. 7. Scribante J, Bhagwanjee S. National audit of critical care resources in South Africa – transfer of critically ill patients. S Afr Med J 2007;97(12):1323-1326. 8. Scribante J, Bhagwanjee S. National audit of critical care resources in South Africa – nursing profile. S Afr Med J 2007;97(12):1315-1318. 9. Bhagwanjee S, Scribante J. National audit of critical care resources in South Africa – unit and bed distribution. S Afr Med J 2007;97(12):1311-1314. 10. Christian MD, Joynt GM, Hick JL, Colvin J, Danis M, Sprung CL. Critical care triage: Recommendations and standard operating procedures for ICU and hospital preparations for an influenza epidemic or mass disaster. Intensive Care Med 2010;36(Suppl 1):s55-s64. [http://dx.doi.org/10.1007/s00134-010-1765-0] 11. Wunsch H. A triage score for admission: A holy grail of intensive care. Crit Care Med 2012;40(1):3133. [http://dx.doi.org/10.1097/CCM.0b013e318236eaa3] 12. Gasperino J. The leapfrog initiative for intensive care unit physician staffing and its impact on intensive care unit performance: A narrative review. Health Policy 2011;102(2-3):223-228. [http://dx.doi. org/10.1016/j.healthpol.2011.02.005] 13. Mathivha LR. ICUs worldwide: An overview of critical care medicine in South Africa. Crit Care 2002;6(1):22-23. [http://dx.doi.org/10.1186/cc1449] 14. Statistics South Africa. Mid-year population estimates 2013. http://www.statssa.gov.za/publications/ P0302/P03022013.pdf (accessed 4 May 2015). 15. Uche EO, Ezomike UO, Chukwu JC, Ituen MA. Intensive care unit admissions in Federal Medical Centre Umuahia south east Nigeria. Niger J Med 2012;21(1):70-73. 16. Wunsch H. Is there a Starling curve for intensive care? Chest 2012;141(6):1393-1399. [http://dx.doi. org/10.1378/chest.11-2819]
Accepted 21 April 2015.
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Outcomes of vitrectomy for advanced diabetic retinopathy at Groote Schuur Hospital, Cape Town, South Africa J C Rice, MB BCh, MRCOphth, FCOphth (SA), MPH (Clinical Research); J Steffen, MB ChB, FCOphth (SA) Division of Ophthalmology, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa Corresponding author: J C Rice (james.rice@uct.ac.za)
Background. Present limitations in primary and secondary prevention of diabetic retinopathy mean that many patients with diabetes present with advanced retinal complications, often requiring surgery (vitrectomy). Objectives. To determine the outcomes of vitrectomy for advanced diabetic retinopathy and to examine context-specific risk factors that may influence outcomes and decisions affecting resource allocation. Methods. This was a retrospective cohort study of 124 vitrectomies with up to 6 months’ follow-up. Results. Visual acuity was 6/60 or worse in the better eye in 23.4% of patients at presentation. The mean visual acuity of the listed eye was 2/60. The fellow eye was considered inoperable in 20.2% of cases. Visual function declined significantly in 26.2% of patients while awaiting surgery. The average waiting time until surgery was 2.9 months (range 1 day - 9 months). Epiretinal membranes were present in 93.6% of cases, and posterior iatrogenic breaks occurred in 49.2%. Silicone oil was used in 24.2%. Visual acuity improved in 54.9%, was unchanged in 30.1%, and worsened in 14.0% of cases at 6 months. Patients with poorer vision at surgery were more likely to improve (odds ratio 2.15; p=0.048). Factors associated with a worse visual outcome were increased age at surgery (p=0.042) and posterior iatrogenic retinal breaks (p=0.007). Renal dysfunction was not associated with worse visual outcomes. Conclusion. Vitrectomy improved or stabilised vision in 85.0% of cases, although outcomes were unpredictable. A long waiting time to surgery contributed to patient morbidity. The presence of renal dysfunction did not predict poorer visual outcomes. S Afr Med J 2015;105(6):496-499. DOI:10.7196/SAMJ.9203
Diabetic blindness is a preventable condition. Unfortunately diabetic screening and early intervention are not yet available for most of the diabetic population in the state sector in South Africa (SA). A recent review of 248 diabetic patients attending a day hospital in Cape Town revealed that only 5.2% had regular annual fundus examinations and only 10.4% were aware that annual fundoscopy was required.[1] Although screening programmes have been piloted or partially implemented in a few localised centres,[2,3] the severe deficiencies in current screening and laser management mean that large numbers of patients present with advanced ocular complications of diabetes. Management of these patients usually requires surgical intervention (vitrectomy), and visual outcomes remain unpredictable. Fifty per cent of vitrectomies performed at Groote Schuur Hospital (GSH), Cape Town, are for the complications of diabetic retinopathy, and we anticipate that the proportion may be similar at other state hospitals. In resource-limited settings it is appropriate to examine the outcomes of retinal surgery and to assess context-specific risk factors that may influence surgical outcomes, as well as decisions affecting resource allocation. We are not aware of any publications of this type from SA state facilities.
Methods
We performed a retrospective cohort study of consecutive patients undergoing diabetic vitrectomy at GSH from January 2012 to December 2012 with up to 6 months’ follow-up. All patients were assessed and listed for surgery by four vitreoretinal consultants (one full-time and three sessional consultants) and one trainee vitreoretinal consultant in the department. Preoperative visual acuities were recorded using Snellen charts. The time from listing for surgery to the date of the operation was recorded, as well as any change in visual acuity during this period. Surgical cancellations or
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postponements were recorded. Routine preoperative tests included an assay for urea and electrolytes. Intraoperative details were recorded by each surgeon. Early (within 1 month) and late postoperative complications were noted. If silicone oil was inserted during the procedure, time until removal of oil was recorded. Postoperative visual acuity was assessed at 3 and 6 months, and cases were considered anatomical successes if the retina was completely attached with no features of proliferation in the absence of a tamponading agent (e.g. silicone oil). All data were collected in Epidata and transferred to STATA 12 (Stata Statistical Software: Release 12, StataCorp, USA) for analysis. Visual acuity was converted to the logarithm of the minimum angle of resolution (LogMAR) for statistical analysis. The χ2 test or Fisher’s exact test was used for categorical variables and Student’s t-test and the rank sum test for continuous variables. Logistic regression was used to examine prognostic factors. The study was approved by the University of Cape Town Human Research Ethics Committee (approval number: HREC 851/2014).
Results
During the study period, 124 vitrectomies were performed on 115 patients, 18 (15.6%) of whom were from rural areas. Seventyone (61.7%) were female. The mean age at surgery was 57 years. Indications for surgery are listed in Table 1. Visual acuity was LogMAR 1.0 (Snellen 6/60) or worse in the better eye in 23.4% of patients at presentation. At the time of listing for surgery, the mean visual acuity of the involved eye was LogMAR 1.45 (Snellen 2/60). Sixty eyes (48.8%) were classified as counting fingers or worse. Three patients had perception of light only (Table 2). The patient’s fellow eye was considered inoperable in 20.2% of cases. The average waiting time until surgery was 2.9 months (range 1 day - 9 months) (Fig. 1). During this time 26.2% of eyes experienced
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RESEARCH
n (%)
Non-clearing vitreous haemorrhage
21 (16.9)
Tractional retinal detachment affecting the macula
37 (29.8)
CTR
20 (16.1)
Macular traction and vitreous haemorrhage
43 (34.7)
Other
3 (2.4)
Total
124
10
Indication
Frequency, n 20
30
Table 1. Indications for surgery
0
CTR = combined tractional rhegmatogenous retinal detachment.
Table 2. Presenting visual acuity of the operated eye
0.0
4 (3.3) 4 (3.3)
0.48
6/18
19 (15.5)
0.6
6/24
9 (7.3)
0.78
6/36
8 (6.5)
1.0
6/60
18 (14.6)
1.3
3/60
1 (0.8)
2.0
CF
39 (31.7)
3.0
HM
18 (14.6)
5.0
PL
3 (2.4)
8.0
Fig. 1. Waiting time for surgery. PL
6/9 6/12
4.0 6.0 Time to surgery (months)
123 (100.0)
HM
0.18 0.3
Total
2.0
n (%)
Vision at surgery
Snellen equivalent
CF
LogMAR acuity
a worsening of visual acuity, dropping from a mean of LogMAR 0.84 to LogMAR 1.84 (Snellen 6/40 to <1/60; p<0.0001). One patient dropped from 6/24 to perception of light only (Fig. 2). Surgery was cancelled or postponed at least once in 15 cases (12.1%). The most common reasons for cancellation were shortage of surgery time on the day (n=7) and poor systemic health with high anaesthetic risk (n=6). In 54 cases (43.5%) estimated glomerular filtration rates revealed moderate renal dysfunction or worse at the time of surgery; nine patients had severe renal dysfunction and two renal failure. All surgeries were performed using the Constellation Vision System (Alcon Laboratories). Surgery was performed by one full-time consultant, three part-time consultants and one trainee vitreoretinal consultant. Fifty-one per cent of procedures were performed using 23-gauge, 48.4% using 20-gauge and 0.8% using 25-gauge instrumentation. Cataract surgery was performed at the same time in 54.0% of cases. Epiretinal membranes were present in 93.6% of patients and any degree of macular traction in 79.0%. Posterior iatrogenic retinal breaks occurred in 49.2% of cases and port-related tears in 7.8%. To achieve intraocular tamponade, silicone oil was used in 24.2% of cases, SF6 gas in 23.4%, C3F8 gas in 7.3%, and air in 7.3%; in 37.9% no tamponade was necessary. Of the patients in whom silicone oil was used (30 cases), 6 (20.0%) had significant haemorrhage under the oil in the early postoperative period. The mean duration of time until the silicone oil was removed was 9.9 months (range 5.3 - 16.8). Raised intraocular pressure (>21 mmHg) was the most common early postoperative complication (43.6%), which persisted in 13.1% of cases at 1 month. A fibrinoid anterior chamber reaction was observed
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6/6
6/60
CF = count fingers; HM = hand motions; PL = perception of light.
6/6
6/60
CF
HM
PL
Vision at listing
Fig. 2. Change in visual acuity while awaiting surgery (logarithmic scale). (CF = count fingers; HM = hand motions; PL = perception of light.)
in 20.9% of cases in which cataract surgery was done at the same time as vitrectomy, compared with only 5.3% of those without concurrent cataract surgery (p=0.02). In 8.0% of cases reoperation was required for residual subretinal fluid or postoperative vitreous haemorrhage. Anatomical success, defined as an attached retina without tamponade and non-progressive diabetic retinopathy, was achieved in 77.1% of cases. Information on visual acuity was available for 113 cases (91.1%) at 3 months and for 93 (75.0%) at 6 months. The mean LogMAR acuity was 1.01 (Snellen 6/60) at 3 months and 0.85 (Snellen 6/40) at 6 months, demonstrating a statistically significant improvement (p=0.01). Visual acuity was improved (by at least 0.3 LogMAR units, n=51) in 54.9%, unchanged (within 0.3 LogMAR units, n=28) in 30.1% and worse (by at least 0.3 LogMAR units, n=13) in 14.0% of cases at 6 months. Four eyes had no perception of light at 6 months secondary to neovascular glaucoma (Fig. 3). In our study, the odds of improved vision at 6 months was statistically related to worse visual acuity at the time of surgery (odds ratio (OR)
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RESEARCH
2.15; p=0.048). Older age at surgery was associated with a reduced likelihood of visual improvement at 6 months (OR 0.92; p=0.042). Poor vision in the other eye (counting fingers or worse) did not increase the risk of poor visual outcome (p=0.58). Avoiding iatrogenic retinal breaks (OR 0.13; p=0.01) was the most important intraoperative factor associated with better visual outcomes. Visual outcomes were best in the eyes that did not require tamponade and worst in those still containing silicone oil at the 6-month acuity evaluation (Table 3).
Discussion
The prevalence of type 2 diabetes in SA increased from 5.5% in 2000 to 9% in 2009.[4] Current estimates are that 9.7% of the population older than 30 years are diabetic[2] and that diabetes causes 8 000 new cases of blindness annually.[4] Good systemic control of blood glucose, hypertension and other risk factors (primary prevention) and early detection and management of diabetic retinopathy (secondary prevention) are well-established strategies in the battle against diabetic blindness. Digital fundus photography screening is established in many developed countries, and Khan et al.[2] have suggested that this is cost-effective in SA. We are pleased to note the recent efforts of Cook and others to highlight and promote screening Table 3. Mean visual acuity at 6 months and tamponading agent Tamponading agent
n
Mean LogMAR acuity
Snellen equivalent
None
35
0.70
6/30
Air
6
1.03
6/60
SF6 gas
20
1.11
6/60
C3F8 gas
7
1.08
6/60
Oil removed
12
0.73
6/30
Oil not yet removed
13
2.03
CF
HM CF 6/6
6/60
Vision at surgery
PL
Silicone oil
6/6
6/60
CF
HM
PL/NPL
Vision at 6 months
Fig. 3. Change in visual acuity from surgery to 6 months (logarithmic scale). (CF = count fingers; HM = hand motions; PL/NPL = perception of light/no perception of light.)
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in SA,[5,6] including quality assurance assessment of the graders of fundus photographs.[7] Unfortunately there are currently virtually no established screening programmes, and patientsâ&#x20AC;&#x2122; systemic control is often poor.[8] In addition, the black African population tends to have more aggressive complications of diabetic retinopathy.[9] As a result, patients are referred to tertiary institutions with advanced levels of pathology requiring surgical intervention. The most common indication for retinal surgery at GSH is the advanced ocular complications of diabetes. Of the patients listed for surgery over our study period, 23.4% were blind in both eyes (counting fingers or worse) and 20.2% had one eye assessed as inoperable at presentation. In addition, the progressive nature of this disease resulted in increased morbidity while patients waited for surgery, with 26.2% of patients suffering further visual loss during this period. In our hands, retinal surgery was able to achieve anatomical success in 77.1% of cases and visual stability or improvement in 85.0%, which compares favourably with other series.[10,11] Overall visual acuity improved from a mean of 2/60 preoperatively to 6/60 at 3 months and 6/40 at 6 months. Seventy-four per cent were graded as 6/60 or better at 6 months, which is similar to a series of 174 cases by Yorston et al.[10] Thirty-three per cent achieved 6/12 or better, which compares favourably with a more recent series from the UK.[11] While Snellen visual acuity is limited in its description of visual function, surgery usually achieves stability in an otherwise progressive condition. Patients whose vision remains unchanged after surgery therefore benefit from the reduced risk of declining visual function with time. Our results support vitrectomy as an efficient use of resources. Of the 93 cases with 6 monthsâ&#x20AC;&#x2122; follow-up, the number of blind eyes (counting fingers or worse) fell from 41 to 24, indicating that approximately one in five vitrectomies reverses blindness. Yorston et al.[10] published a similar figure of one in seven procedures. The time between listing for surgery and the operation has been found to be an important negative predictor of visual outcomes.[11] This is a particularly important factor in resource-limited settings. In previous years, the waiting time in our department was longer than 9 months. With additional theatre time and selection of cases, we reduced the waiting time to an average of 2.9 months (range 1 day - 9 months) at the time of the study. Visual function declined in 26.2% of our patients during this period. It is likely that waiting times to surgery will continue to be under pressure given the rising prevalence of diabetes and limited secondary prevention strategies in place in SA. The progressive nature of diabetic retinopathy means that prolonged waiting times are also likely to result in more inoperable eyes. In addition, delays in removing silicone oil result in higher rates of oil-related complications such as raised intraocular pressure. It is an unfortunate reality that criteria for surgery are often changed in order to cope with rising patient numbers. Eyes with a more guarded prognosis may not be offered surgery, or surgery may only be performed on the eye with the better prognosis. The decision whether or not to perform surgery should be based on the best available evidence and balanced with available resources. A number of researchers have attempted to identify preoperative features associated with poor outcome that may be of value in resource-limited environments. Apart from delayed surgery, other factors associated with poorer outcome include older age at surgery,[12] poor preoperative visual acuity,[10,12] poor vision in the other eye at presentation,[10] iris new vessels,[12] poor clinic attendance[11] and retinal detachment involving the macula,[10] particularly if longstanding.[12] Extensive vitreoretinal adhesions are also associated with poorer outcomes,[10] but this finding is sometimes only deterÂmined intraoperatively, making it less useful in patient selection for surgery. Unfortunately, many of our patients present for the first time with many of these poor prognostic features,
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making selection of those likely to benefit from surgery more difficult. It is helpful to note that systemic factors such as hypertension, previous stroke, renal failure and a history of foot ulceration or amputation[10,12] should not be criteria for exclusion unless they pose a high anaesthetic risk or current risk of infection. We currently offer surgery for one eye if the patient presents with bilateral poor prognostic features. We use the presence of a relative afferent pupil defect and ability to identify correctly the position of a light source (projection) as important clinical criteria for selection in patients with perception of hand motions or light vision only. Many patients presenting with unilateral poor-prognosis eyes will only be offered surgery for the eye with the better prognosis. Our goal is to benefit the maximum number of patients with our current resources. It is important to note that some patients with poor prognostic features do well,[10] as was the case in our series. This puts additional pressure on the clinician to perform surgery, which is not always possible in resource-limited settings.
Study limitations
Our study has a number of limitations. It was a retrospective analysis that relied on accurate data entry in case notes. Acuity data at 6 months were only available for 75% of cases, and best visual acuity was based on pinhole testing, as few patients receive refractive correction at our hospital. The degree of macular traction was not specified and would have ranged from minimal traction to complete detachment of the macula, which would have influenced prognosis significantly. In addition, we did not grade the degree of cataract and assume that visually significant cataracts were operated on. We also did not grade the degree of previous laser treatment or vitreoretinal attachments, as suggested by Yorston et al.,[10] who found the latter to be an important prognostic factor. Despite these limitations we were encouraged by the overall success of surgery in our hands. Preoperative bevacizumab (Avastin) was not used during the study period. It has been shown in large studies to reduce surgery time, reduce the need for endocautery and decrease the number of iatrogenic breaks. [13] We now regularly use bevacizumab (off-label) a few days before surgery in eyes with active neovascularisation, which may further improve our outcomes. In addition, the introduction of smaller-gauge (23- and 25-gauge) instruments and bimanual techniques may be associated with fewer posterior iatrogenic breaks.[14] We plan further analysis in our hospital as these techniques and technologies are adopted.
499
Conclusion
This study represents the current retinal surgery practice at our centre. The results are in keeping with other publications, and are encouraging given our patients’ advanced level of pathology at presentation. They provide useful information for patients regarding surgical outcomes. We recognise the need to keep waiting times for surgery as short as possible, which is likely to become more difficult given the diabetes epidemic. Improvement in primary and secondary preventive strategies is essential in SA and will reduce the number of patients presenting with advanced diabetic eye disease. References 1. Read O, Cook C. Retinopathy in diabetic patients evaluated at a primary care clinic in Cape Town. S Afr Med J 2007;97(10):941-942,944. 2. Khan T, Bertram MY, Jina R, Mash B, Levitt N, Hofman K. Preventing diabetes blindness: Cost effectiveness of a screening programme using digital non-mydriatic fundus photography for diabetic retinopathy in a primary health care setting in South Africa. Diabetes Res Clin Pract 2013;101(2):170176. [http://dx.doi.org/10.1016/j.diabres.2013.05.006] 3. Mash B, Powell D, du Plessis F, van Vuuren U, Michalowska M, Levitt N. Screening for diabetic retinopathy in primary care with a mobile fundal camera – evaluation of a South African pilot project. S Afr Med J 2007;97(12):1284-1288. 4. Bertram MY, Jaswal AVS, van Wyk VP, Levitt NS, Hofman KJ. The non-fatal disease burden caused by type 2 diabetes in South Africa, 2009. Glob Health Action 2013;6:19244. [http://dx.doi.org/10.3402/gha.v6i0.19244] 5. Cook S. Diabetic retinopathy – the Ophthalmology Society of Southern Africa screening programme. S Afr Med J 2013;103(7):449-451. [http://dx.doi.org/10.7196/SAMJ.7136] 6. Hofman KJ, Cook C, Levitt N. Preventing diabetic blindness: A priority for South Africa. S Afr Med J 2014;104(10):661-662. [http://dx.doi.org/10.7196/SAMJ.8580] 7. Cook S, Staff RT, Goatman KA, Olson JA, Scottish Diabetic Retinopathy Screening collaborative. Quality assurance in diabetic retinal screening in South Africa. S Afr Med J 2014;104(10):700-704. [http://dx.doi.org/10.7196/SAMJ.8678] 8. Webb EM, Rheeder P, van Zyl DG. Diabetes care and complications in primary care in the Tshwane district of South Africa. Prim Care Diabetes 2015;9(2):147-154. [http://dx.doi.org/10.1016/j.pcd.2014.05.002] 9. Thomas RL, Distiller L, Luzio SD, et al. Ethnic differences in the prevalence of diabetic retinopathy in persons with diabetes when first presenting at a diabetes clinic in South Africa. Diabetes Care 2013;36(2):336-341. [http://dx.doi.org/10.2337/dc12-0683] 10. Yorston D, Wickham L, Benson S, Bunce C, Sheard R, Charteris D. Predictive clinical features and outcomes of vitrectomy for proliferative diabetic retinopathy. Br J Ophthalmol 2008;92(3):365-368. [http://dx.doi.org/10.1136/bjo.2007.124495] 11. Gupta B, Sivaprasad S, Wong R, et al. Visual and anatomical outcomes following vitrectomy for complications of diabetic retinopathy: The DRIVE UK study. Eye (Lond) 2012;26(4):510-516. [http:// dx.doi.org/10.1038/eye.2011.321] 12. La Heij EC, Tecim S, Kessels AGH, Liem ATA, Japing WJ, Hendrikse F. Clinical variables and their relation to visual outcome after vitrectomy in eyes with diabetic retinal traction detachment. Graefes Arch Clin Exp Ophthalmol 2004;242(3):210-217. [http://dx.doi.org/10.1007/s00417-0030815-5] 13. Zhang Z-H, Liu H-Y, Hernandez-Da Mota SE, et al. Vitrectomy with or without preoperative intravitreal bevacizumab for proliferative diabetic retinopathy: A meta-analysis of randomized controlled trials. Am J Ophthalmol 2013;156(1):106.e2-115.e2. [http://dx.doi.org/10.1016/j.ajo.2013.02.008] 14. Gosse E, Newsom R, Lochhead J. The incidence and distribution of iatrogenic retinal tears in 20-gauge and 23-gauge vitrectomy. Eye (Lond) 2012;26(1):140-143. http://dx.doi.org/10.1038/eye.2011.289]
Accepted 5 December 2014.
June 2015, Vol. 105, No. 6
GUEST EDITORIAL
Trauma care – the Eastern Cape story While I am writing this editorial, the bloodshed seen in the casualty, emergency and trauma units across the Eastern Cape province still harbours fresh in my memory. An estimated 48 000 South Africans are killed as a result of trauma-related events annually, with a further 3.5 million seeking healthcare as a result of trauma.[1,2] South Africa (SA)’s injury death rate is nearly twice the global average.[3] Rising levels of poverty and unemployment, limited access to education, abuse of alcohol and drugs, widespread access to firearms and other weapons, exposure to violence in childhood and a weak culture of enforcement are just a few of the multiple factors contributing to this carnage. The government has implemented programmes and campaigns to address these issues. These efforts may have contributed to a decrease in the percentage of non-natural deaths from 18% in 1997 to 10% in 2013, but even the latter percentage is too high.[2] Diabetes, hypertension and HIV are all preventable, and so is violence. Having campaigns and strategies in place to curb violence and address the underlying contributing factors is vital. Both transport accident- and assault-related deaths as a percentage of total nonnatural deaths in the Eastern Cape are worryingly higher than the national average, i.e. 11.6% v. 11% and 15.7% v. 10.2%, respectively. The values are in keeping with the higher levels of poverty in the province.[2] However, the ability to provide quality care to the victims of these injuries is similarly important. The management of a trauma patient involves a sufficient number of highly qualified and trained individuals. Contrary to popular belief, the most critical time of intervention is at the roadside or place of injury, where the emergency medical services (EMS) need to come to the fore. A letter published in the SAMJ in 2010[4] highlighted the deficiencies of the Eastern Cape EMS. The Metro Eastern Cape EMS responded to only 3.3% of calls within an hour. Without early resuscitation and stabilisation, the sustained efforts at a later stage in a hospital setting may prove costly and even fruitless. The situation has somewhat improved, with the provincial department purchasing 150 emergency service vehicles in 2014, with the objective of attending to patients within 40 minutes.[5] Despite being the second largest and third most populous province, the Eastern Cape does not have a specialist trauma surgeon. This is not due to a lack of available posts or funding, but rather to an inadequate number of prospective applicants. The trauma patients at the three tertiary-level public health facilities, i.e. the Mthatha, Port Elizabeth and East London Hospital complexes, are managed by a team of general surgeons. The situation is not much rosier in the private sector, where, to our knowledge, there is no specialist trauma surgeon. Outside of the three complexes, the patients are managed at the peripheral hospitals – mainly by community service and junior medical officers and a few senior colleagues. Consequently, most, if not all, of the after-hours potential theatre cases are referred to one of the three complexes for surgical intervention, creating huge backlogs and waiting times. To improve the quality of care delivered to patients in the province, a few junior medical officers and consultants working in the surgical
500
disciplines at the East London Hospital Complex produced a book, Surgery Survival Guide. What started as a 50-page document in 2013, has grown to a 200-page surgical handbook in 2015, focusing purely on the management of common surgical emergencies, including trauma, general surgery, neurosurgery, urology, paediatric surgery, orthopaedics and intensive care. With the aid of funding from the provincial department of health, the book is now widely circulated across all health facilitates in the province. The text is very much a work in progress and it needs to be seen whether it will stand the test of time … but Rome was not built in a day. The Guide is just one of the initiatives and changes that needs to take place to improve trauma care in the province. Emphasis needs to be placed on every level of care – encouraging personnel to work in the discipline, improving their skill sets from prehospital care to definitive care, rehabilitation and discharge. Not only the Eastern Cape, but the entire country is gripped by an epidemic of deliberate and non-deliberate traumatic events. These events are propagated by a background of alcohol, violence and substance abuse. The huge burden of disease, together with poor prehospital care, limited expertise and in-house training, contributes to the gross inequities that exist in our current trauma care system. The Eastern Cape has much room for improvement and the potential to be one of the leading trauma and emergency care providers in SA. The burdens we face create unique opportunities for healthcare professionals and personnel to strive to create a healthcare system that our patients deserve. J John Guest editor Department of Urology, Frere Hospital, East London Hospital Complex, East London, South Africa jeffveenajohn@gmail.com W Matshoba Guest editor Head, Department of Surgery, Frere Hospital, East London Hospital Complex, East London, South Africa 1. Pillay K, Ross A, Van der Linde S. Trauma unit workload at King Edward VIII Hospital, Durban, KwaZulu-Natal. S Afr Med J 2012;102:307-308. 2. Mortality and Causes of Death in South Africa: Findings from Death Notification, 2013. Statistics South Africa. http://www.statssa.gov.za/publications/P03093/CoD_2013_presentation.pdf (accessed 8 May 2015). 3. Matzopoulos R, Norman R, Bradshaw D. The burden of injury in South Africa: Fatal injury trends and international comparisons. In: Suffle S, Van Niekerk A, Duncan N, eds. Crime Violence and Injury Prevention in South Africa: Developments and Challenges. Tygerberg: MRC-UNISA Crime, Violence and Injury Lead Programme, 2004:9-21. 4. Meents E, Boyles T. Emergency medical services – poor response time in the Eastern Cape. S Afr Med J 2010;100:790. 5. E Cape gets new ambulances. SABC News, 28 July 2014. http://www.sabc.co.za/news/ a/87852a8044e576c3ade1bda5ad025b24/E-Cape-gets-new-ambulances (accessed 8 May 2015).
S Afr Med J 2015;105(6):500. DOI:10.7196/SAMJ.9794
June 2015, Vol. 105, No. 6
CONTINUING MEDICAL EDUCATION
INTRODUCTION
Introduction to algorithms for managing the common trauma patient L Wallis, MB ChB, MD, DIMCRCSEd, Dip Sport Med, FRCS (Edin), FRCP (Edin), FRCEM, FCEM (SA), FEMSSA, FIFEM Division of Emergency Medicine, Department of Surgery, Faculty of Health Sciences, University of Cape Town; Division of Emergency Medicine, Department of Interdisciplinary Health Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University; and Emergency Medicine, Western Cape Government, Cape Town, South Africa Corresponding author: L Wallis (lee.wallis@uct.ac.za)
It has been four years since I wrote an editorial in the SAMJ[1] relating to the problems of trauma in South Africa (SA). I was more optimistic, naïve perhaps, and looking for meaningful change. In the face of the daily carnage from road accidents and interpersonal violence, I asked, ‘is 2011 the year we will stand up and do something?’[1] – apparently not. We continue to face the same onslaught, the same 1 200 deaths on our roads each month, and the same number of violent attacks of one man (it is usually men) on another human being.[2] Trauma is an epidemic and, as with any other epidemic, demands policy intervention, preventive measures and provision of care. The factors that drive SA’s levels of violence are complex and difficult to address. We have policies, but poor implementation. We know that prevention is better than cure and that prevention efforts are critical and must be supported at all levels. But prevention – real prevention – to bring us to ‘acceptable’ injury levels, will take years or even decades. Globally, 4.8 million people die of trauma each year compared with 3.8 million who die of HIV/AIDS, tuberculosis (TB) and malaria combined. A single type of trauma – road injury – was the fifth leading global cause of death by 2013, ahead of HIV.[3] The myriad reasons behind the gross mismatch of disease burden and funding efforts are beyond the scope of this introduction, but perhaps we now see the first small steps towards normalisation. After reports such as that of the World Bank,[4] injury is finally being recognised as a problem: two key steps include the recommendations of the Lancet Surgical Commission,[5] and the World Health Organization (WHO)’s recent moves to appoint a lead for Emergency, Trauma and Acute Care and strengthen the Global Alliance for Care of the Injured. In the meantime, in SA, better care of the injured must be a higher priority for a health system traditionally vertically orientated to HIV/
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AIDS and TB. Effective early care dramatically improves outcome, perhaps by as much as 45% for deaths and 36% for disability.[6] The need for effective trauma care cannot be more eloquently expressed than by Kobusingye et al.,[7] when 10 years ago they noted that ‘Emergencies occur everywhere, and each day they consume resources regardless of whether there are systems capable of achieving good outcomes’. It is our responsibility – your responsibility – as front-line clinicians, to provide the best care we can for the victims of trauma. Those of you facing injured patients in your clinical practice know that sources of advice for care come in many formats and from many sources, and that some are easier to use than others. In this edition of CME, John[8] provides simple flowchart-based algorithms to guide that care. His recommendations are in line with international and national guidelines, easy to follow, and – with the exception of a small number of advanced imaging requirements – implementable at all levels of care. We may not be making much impact on the numbers of injured patients that we see daily, but we can impact on the care they receive. 1. Wallis LA. Trauma care in South Africa – a call to arms. S Afr Med J 2011;101(3):171. 2. Statistics South Africa. http://www.statssa.gov.za/publications/P03093/P030932013.pdf (accessed 18 May 2015). 3. GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: A systematic analysis for the Global Burden of Disease Study 2013. Lancet 2015; 385:117-171. [http://dx.doi.org/10.1016/S01406736(14)61682-2] 4. Marquez PV, Farrington JL. The Challenge of Non-Communicable Diseases and Road Traffic Injuries in Sub-Saharan Africa. An Overview. Washington, DC: The World Bank, 2013. 5. Meara JG, Leather AJM, Hagander L, et al. Global surgery 2030: Evidence and solutions for achieving health, welfare, and economic development. Lancet 21 April 2015. [Epub ahead of print] [http://dx.doi. org/10.1016/S0140-6736(15)60160-X] 6. Jamison D, Breman JG, Measham AR, et al., eds. Disease Control Priorities in Developing Countries. 2nd ed. Washington, DC: World Bank, 2006. http://www.ncbi.nlm.nih.gov/books/NBK11728/ (accessed 15 November 2012). 7. Kobusingye OC, Hyder AA, Bishai D, et al. Emergency medical systems in low- and middle-income countries: Recommendations for action. Bull World Health Organ 2005;83(8):626-631. 8. John J. Algorithms for managing the common trauma patient. S Afr Med J 2015;105(6):502-507. [http://dx.doi.org/10.7196/SAMJ.9795]
S Afr Med J 2015;105(6):501. DOI:10.7196/SAMJ.15
June 2015, Vol. 105, No. 6
CONTINUING MEDICAL EDUCATION
ALGORITHMS
Algorithms for managing the common trauma patient J John, MB ChB Department of Urology, Frere Hospital, East London Hospital Complex, East London, South Africa Corresponding author: J John (jeffveenajohn@gmail.com)
Approach to penetrating abdominal trauma Haemodynamically unstable
ATLS principles â&#x2C6;&#x2019; A, B, C, D & E
Haemodynamically stable
Resuscitate with 2 L crystalloid solution and monitor response
Complete primary survey (adjuncts, SAMPLE history) Admit for observation and serial examinations
Consider blood transfusion
Still unstable
No
FAST/USS
Yes
Complete secondary survey
_ Assess for other causes of shock
Peritonitis Bowel evisceration Fluid refractory haemorrhagic shock Free air under the diaphragm Diaphragmatic herniation Blood in NG tube
+ Yes
Emergency laparotomy
No Clinical deterioration Peritonitis Decreasing haemoglobin
See Figs 7 and 8
Yes
Frank haematuria with flank/back wounds No
Yes EUA in theatre Admit for observation and serial examinations
Discharge
Deep to deep fascia
Superficial to deep fascia
Clean and suture
Rectal bleeding No
Local wound exploration
Fig. 1. Approach to penetrating abdominal trauma (ATLS = advanced trauma life support; FAST/USS = focused assessment with sonography in trauma/ ultrasound scan; EUA = examination under anaesthesia; CT = computed tomography; NG = nasogastric; SAMPLE = signs and symptoms, allergies, medications, pertinent medical history, injuries, illnesses, last meal/intake, events leading up to the injury and/or illness).
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Approach to blunt abdominal trauma Haemodynamically unstable
Admit for observation and serial examinations
Resuscitate with 2 L crystalloid solution and monitor response Consider blood transfusion
Complete primary survey (adjuncts, SAMPLE history) Complete secondary survey
Abdomen soft, non-tender
FAST/USS (if unavailable)
Yes No
YesStill unstable
Haemodynamically stable
ATLS principles â&#x2C6;&#x2019; A, B, C, D & E
Acute abdomen
FAST/USS (if available)
No
Yes
Yes
Emergency laparotomy
Free fluid or clinical uncertainty
Solid organ injury
CT abdomen
Consider CT abdomen
Hollow viscous injury
Clinical deterioration Peritonitis Decreasing haemoglobin
Solid organ injury
Normal
Admit for observation and serial examinations
Fig. 2. Approach to blunt abdominal trauma (ATLS = advanced trauma life support; FAST/USS = focused assessment with sonography in trauma/ultrasound scan; CT = computed tomography; SAMPLE = signs and symptoms, allergies, medications, pertinent medical history, injuries, illnesses, last meal/intake, events leading up to the injury and/or illness).
Approach to penetrating chest trauma (central chest wall) HaemodynamicallyUnstable unstable Haemodynamically
ATLS principles â&#x2C6;&#x2019; A, B, C, D & E
Haemodynamically stable
Erect CXR
No
Clinical features of tension pneumothorax, pneumothorax or haemothorax Yes
Haemothorax Pneumothorax
Minimal or no pneumothorax
Insert ICD
No
Clinical improvement?
Insert ICD
Clinical features of cardiac tamponade
Repeat CXR in 4 - 6 hours
Yes
Yes
Yes
Bleeding >1 500 mL or >200 mL/hour
Yes Stable
Increase in size of pneumothorax
Unstable
No Observe and manage as appropriate
Clinical deterioration
_
FAST/ ECHO
+
Consider
+ Pericardiocentesis
Thoracotomy
FAST/ECHO _
Observe and manage as appropriate
Fig. 3. Approach to penetrating chest trauma (central chest wall) (ATLS = advanced trauma life support; ICD = intercostal drain; FAST/ECHO = focused assessment with sonography in trauma/echocardiography; CXR = chest X-ray).
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Approach to penetrating chest trauma (lateral chest wall) HaemodynamicallyUnstable unstable Haemodynamically
ATLS principles â&#x2C6;&#x2019; A, B, C, D & E
Haemodynamically stable
Erect CXR
No
Clinical features of tension pneumothorax, pneumothorax or haemothorax Yes
Haemothorax Pneumothorax
Minimal or no pneumothorax
Insert ICD
No
Clinical improvement?
Insert ICD
Clinical features of cardiac tamponade
Repeat CXR in 4 - 6 hours
Yes
Yes
Yes Bleeding >1 500 mL or >200 mL/hour
Yes Stable
_
Observe and manage as appropriate
FAST/ ECHO
Unstable
+
Pericardiocentesis
Consider
Clinical deterioration
Increase in size of pneumothorax
Observe and manage as appropriate
Thoracotomy
Fig. 4. Approach to penetrating chest trauma (lateral chest wall) (ATLS = advanced trauma life support; ICD = intercostal drain; FAST/ECHO = focused assessment with sonography in trauma/echocardiography; CXR = chest X-ray).
Approach to penetrating neck trauma
Haemodynamically stable
ATLS principles â&#x2C6;&#x2019; A, B, C, D & E
Haemodynamically unstable
Active arterial bleeding Rapidly expanding haematoma Absent radial pulse Air bubbling through wound Respiratory distress
Yes
Emergency neck exploration
Insert ICD if evidence of haemo-/pneumothorax
No Observe and manage as appropriate
No
Zone II (between the cricoid cartilage and angle of the mandible)
Yes
Zone III (above angle of mandible)
Zone I (inferior to cricoid cartilage) Chest X-ray C-spine X-ray Angiogram Endoscopy Spiral CT chest
Did injury penetrate platysma muscle?
Rule out pneumothorax Check for fractures, foreign bodies, air in soft tissues Suspected vascular injury (haematoma, bruit, neurological fallout, BP difference >10 mmHg in each arm, widened mediastinum) Suspected oesophageal injury (dysphagia/odynophagia) Suspected aortic injury
C-spine X-ray Angiogram Laryngoscopy Sialogram
Suspected pharyngeal injury Suspected parotid gland injury
Fig. 5. Approach to penetrating neck trauma (ATLS = advanced trauma life support; ICD = intercostal drain; CT = computed tomography; C-spine = cervical spine; BP = blood pressure).
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Approach to penetrating limb trauma
Any hard signs
ATLS principles â&#x2C6;&#x2019; A, B, C, D & E
Any evidence of distal ischaemia Absent or diminished pulses Active bleeding Expanding or pulsatile haematoma Audible bruit Palpable thrill
No
Measure Doppler pressures (ankle brachial index) and compare with unaffected limb
Yes >0.9
<0.9
Observe and manage as appropriate
Multiple sites of entry Extensive bone and soft tissue damage Pre-existing vascular disease
Yes
Angiogram
No
Emergency limb exploration
Fig. 6. Approach to penetrating limb trauma (ATLS = advanced trauma life support).
Approach to frank haematuria in trauma (bladder and renal injuries) Haemodynamically unstable
Resuscitate with 2 L crystalloid solution and monitor response Consider blood transfusion
Still unstable
No
Yes
Haemodynamically stable
ATLS principles â&#x2C6;&#x2019; A, B, C, D & E
Blunt trauma
Penetrating trauma
_
FAST/USS +
Emergency laparotomy
Pelvic fracture
No
Yes Cystogram or CT cystogram
Isolated extraperitoneal bladder rupture
Renal injury Yes
Bladder injury
Intraperitoneal bladder rupture
Admit for conservative management 1. Urethral catheter for 10 days 2. IV antibiotics 3. Repeat cystogram at 10 days
CT abdomen with delayed phase for ureter views
Yes
Emergency laparotomy
Haemodynamic instability Suspected renal pelvis injury Renal artery thrombosis Other intraperitoneal visceral damage No Admit for conservative management
Clinical deterioration Peritonitis
1. Strict bed rest 2. IV antibiotics 3. Serial abdominal examinations
Fig. 7. Approach to frank haematuria in trauma (bladder and renal injuries) (ATLS = advanced trauma life support; IV = intravenous; FAST/USS = focused assessment with sonography in trauma/ultrasound scan; CT = computed tomography).
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CONTINUING MEDICAL EDUCATION Approach to frank haematuria in trauma (urethral injuries) ATLS principles − A, B, C, D & E Emergency exploration and insertion of suprapubic catheter
Complete primary survey (adjuncts, SAMPLE history) Complete secondary survey
Suspected urethral injury with blood at the external urethral meatus
Penetrating injury
Blunt injury
Incomplete injury (slight extravasation, contrast enters bladder)
Complete injury (extravasation, contrast does not enter bladder)
Ascending urethrogram
Insert transurethral catheter
Insert suprapubic catheter If fails
Fig. 8. Approach to frank haematuria in trauma (urethral injuries) (ATLS = advanced trauma life support; SAMPLE = signs and symptoms, allergies, medications, pertinent medical history, injuries, illnesses, last meal/intake, events leading up to the injury and/or illness).
Approach to head injury ATLS principles − A, B, C, D & E Multiple system injuries/polytrauma
Isolated head injury
Discharge with head injury form
Check A, B, C
Haemodynamically unstable
1. 2. 3. 4. 5. 6. 7. 8.
No deterioration
Observe 4 - 6 hours CXR
FAST/USS +
+
ICD
Consider laparotomy Still unstable
Pelvic X-ray
No
Yes
Examine limbs ± X-rays
+
GCS <13 at any point since injury GCS <15 2 hours since injury Suspected open/depressed fracture Focal neurological deficit Post-traumatic seizure Any penetrating head/orbital injury >1 episode of vomiting since injury LOC/amnesia in patients >65 years, with coagulopathies or dangerous mechanism of injury
Deteriorates
Yes
CT scan (uncontrasted) and preferably with C-spine
+
Consider angio-embolisation ± external fixation
Normal CT/only simple skull fracture Splint
Intracranial injury/depressed or compound skull fracture
Admit ± theatre (discuss with neurosurgeon)
Thoracotomy
Fig. 9. Approach to head injury (ATLS = advanced trauma life support; CXR = chest X-ray; FAST/USS = focused assessment with sonography in trauma/ultrasound scan; ICD = intercostal drain; GCS = Glasgow Coma Scale; LOC = loss of consciousness; CT = computed tomography; C-spine = cervical spine).
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Acknowledgement. A special thank you to the consultants at Frere Hospital for reviewing the algorithms and perfecting them for publication, especially Drs W Matshoba, K Kesner, E Simpson, D Brown and A Makangee. The contribution of the Eastern Cape Department of Health in providing funding for the printing and circulation of the algorithms and the Surgery Survival Guide handbook is gratefully acknowledged. A special word of appreciation to Prof. G Boon for driving this process from start to finish.
Further reading American College of Surgeons, Committee on Trauma. ATLS: Advanced Trauma Life Support® Program for Doctors (ATLS®). Student Manual. 6th ed. Chicago, IL: American College of Surgeons, 1997. Heyns C, Barnes D. Introduction to Urology. Cape Town: South African Urology Association. John J, ed. Surgery Survival Guide. East London: Eastern Cape Department of Health, 2015. Nicol A, Steyn E, eds. Handbook of Trauma for Southern Africa. 3rd ed. Cape Town: Oxford University Press Southern Africa, 2010. Welzel T. Emergency Medicine Guidance for the Western Cape. Revised ed. Cape Town: Western Cape Department of Health, 2013.
S Afr Med J 2015;105(6):502-507. DOI:10.7196/SAMJ.9795
PULSE E-mpowering the patient: Electronic health record centralises patient data
The proliferation of technology, the internet and social media has created a whole new world with a new set of expectations. The highly connected and increasingly empowered consumer living in today’s digital age expects highly personalised solutions, relevant experiences and immediate gratification – and today’s patient is no different. This has led to the rise in medical technologies such as apps, wearables and eHealth, aimed at empowering the consumer to take greater personal responsibility for managing their health. ‘Medical technologies hold huge potential for both patients and service providers alike,’ said Dr Ali Hamdulay of Metropolitan Health. ‘It is important to leverage these technologies to develop innovative, personalised health solutions that support sustainable behaviour change. Designed to encourage patients to take greater responsibility for their health, Metropolitan recently launched its electronic health record (EHR), which aims to improve medical efficiencies, reduce wastage and promote patient-centric care.’ Metropolitan’s patient-driven EHR empowers the patient to take charge of their health. The patient has complete control over access to the record, which has been developed in line with the Protection of Personal Information Act, ensuring confidentiality of information at all times. The patient is supported throughout their healthcare journey, as the platform forms a central hub of medical information that can move with the patient from provider to provider, as opposed to residing with an individual practice. The information is available wherever and whenever it is needed, promoting the seamless flow of information between providers and transforming the way care is delivered. With a full patient record and medical history housed in the EHR, it is possible for providers to practise more direct and specific care.
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The patient has complete control over their EHR and can choose to share it with any provider, including pharmacists. By sharing it with a new doctor, they are able to provide an immediate, up-to-date report of their medical history and current state of health, which will provide a basis to continue care. ‘This eliminates the need to run duplicate tests and develop new patient profiles, ultimately empowering providers to make better informed decisions quicker, improving patient outcomes,’ said Dr Hamdulay. A unique username and password will grant the patient access to their EHR via a desktop or mobile device. A patient can share the record with their doctor during consultation, or the doctor can request access to the record prior to an appointment via the provider portal. The patient will need to grant permission before the provider is able to view their record. Once entry is granted, the provider has access to the member’s current conditions, allergies, acute and chronic medication, pathology claims and results, hospitalisations, provider visits and consultations – as well as any other acute claims for allied healthcare providers, such as physiotherapy. There are plans to include radiological images in the record at a later stage. ‘Empowering the patient is an important component of today’s healthcare system. While the provider is essential in co-ordinating care, the patient needs to take responsibility for their own health and wellbeing, instead of relying solely on a third party to pick up if something is wrong,’ said Dr Hamdulay. ‘The patient is regularly updated on their health status, as the record is constantly fed with the latest data. Therefore, while the provider is a powerful motivator, the intrinsic motivation to improve healthy behaviour is patient orientated,’ he concluded.
June 2015, Vol. 105, No. 6
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True (A) or false (B): SAMJ Non-alcohol-related Wernicke’s encephalopathy (WE) 1. Non-alcohol-related WE tends to be more catastrophic in onset and less likely to present with the classic features than WE associated with alcohol abuse. 2. The recommended first-line treatment of WE is thiamine 100 mg orally, continued daily until recovery. Cost analysis of operative repair of major laparoscopic bile duct injuries (BDIs) 3. The cost of repair of a major laparoscopic BDI is substantial (from ZAR100 000 to ZAR1 million), because of the need for prolonged hospital admission, complex surgical intervention and intensive imaging. 4. M ajor BDI is typically associated with a lengthy rehabilitation period, decreased quality of life, loss of income, and in some cases (particularly in the present SA medicolegal environment) risk of litigation. Prehospital cooling of severe burns 5. Application of iced water to burns for 10 - 20 minutes early after the injury improves healing and reduces complications. The South African Surgical Outcomes Study 6. Most patients in South Africa (SA)’s public sector hospitals undergo urgent and emergency surgery, which is strongly associated with mortality and unplanned critical care admissions.
Outcomes of vitrectomy for advanced diabetic retinopathy 10. Many SA patients with diabetic retinopathy present with advanced retinal complications that require vitrectomy. CME Approach to penetrating abdominal trauma 11. A falling haemoglobin level is an indication for an emergency laparotomy. Approach to blunt abdominal trauma 12. Clinical uncertainty is an indication for a computed tomography (CT) scan of the abdomen. Approach to penetrating chest trauma (central chest wall) 13. Bleeding of >200 mL/hour is an indication for thoracotomy. Approach to penetrating chest trauma (lateral chest wall) 14. An erect chest X-ray can be carried out in a haemodynamically stable patient. Approach to penetrating neck trauma 15. In an injury that penetrated the platysma muscle, in zone 1 a chest X-ray is required to rule out pneumothorax. Approach to penetrating limb trauma 16. Emergency limb exploration is indicated if there are multiple sites of entry.
Impact of acute preoperative beta-blockade on perioperative cardiac morbidity and all-cause mortality in hypertensive vascular surgery patients 7. Acute initiation of β-blockade following non-cardiac surgery is associated with an increased risk of adverse outcomes, probably as a consequence of perioperative haemodynamic instability.
Approach to frank haematuria in trauma (bladder and renal injuries) 17. Isolated extraperitoneal bladder rupture is treated conservatively.
Granulomas at initial diagnosis of Crohn’s disease (CD) signal a poor outcome 8. Over time, most patients with CD develop strictures or fistulas. 9. Aggressive medical therapy of CD with immunomodulators such as azathioprine or methotrexate and biologicals early in the disease course is recommended to improve long-term outcomes, but carries a risk of infections and malignancy.
Approach to head injury 19. In an isolated head injury with no episode of vomiting since the injury, observe for 4 - 6 hours. If there is no deterioration, discharge with a head injury form. 20. In an isolated head injury in a patient >65 years, a non-contrast CT scan of the head with cervical spine is indicated.
Approach to frank haematuria in trauma (urethral injuries) 18. A penetrating injury is an indication for emergency exploration and insertion of a urethral catheter.
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